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Species-specific pace of development is associated with differences in protein stability – Science Magazine

By daniellenierenberg

Setting the tempo for development

Many animals display similarities in their organization (body axis, organ systems, and so on). However, they can display vastly different life spans and thus must accommodate different developmental time scales. Two studies now compare human and mouse development (see the Perspective by Iwata and Vanderhaeghen). Matsuda et al. studied the mechanism by which the human segmentation clock displays an oscillation period of 5 to 6 hours, whereas the mouse period is 2 to 3 hours. They found that biochemical reactions, including protein degradation and delays in gene expression processes, were slower in human cells compared with their mouse counterparts. Rayon et al. looked at the developmental tempo of mouse and human embryonic stem cells as they differentiate to motor neurons in vitro. Neither the sensitivity of cells to signals nor the sequence of gene-regulatory elements could explain the differing pace of differentiation. Instead, a twofold increase in protein stability and cell cycle duration in human cells compared with mouse cells was correlated with the twofold slower rate of human differentiation. These studies show that global biochemical rates play a major role in setting the pace of development.

Science, this issue p. 1450, p. eaba7667; see also p. 1431

What determines the pace of embryonic development? Although the molecular and cellular mechanisms of many developmental processes are evolutionarily conserved, the pace at which these operate varies considerably between species. The tempo of embryonic development controls the rate of individual differentiation processes and determines the overall duration of development. Despite its importance, however, the mechanisms that control developmental tempo remain elusive.

Comparing highly conserved and well-characterized developmental processes in different species permits a search for mechanisms that explain differences in tempo. The specification of neuronal subtype identity in the vertebrate spinal cord is a prominent example, lasting less than a day in zebrafish, 3 to 4 days in mouse, and around 2 weeks in human. The development of the spinal cord involves a well-defined gene regulatory program comprising a series of stereotypic changes in gene expression, regulated by extrinsic signaling as cells differentiate from neural progenitors to postmitotic neurons. The regulatory program and resulting neuronal cell types are highly similar in different vertebrates, despite the difference in tempo between species. We therefore set out to characterize the pace of differentiation of one specific neuronal subtypemotor neuronsin human and mouse and to identify molecular differences that explain differences in pace. To this end, we took advantage of the in vitro recapitulation of in vivo developmental programs using the directed differentiation of human and mouse embryonic stem cells.

We found that all stages of the developmental progression from neural progenitor to motor neuron were proportionally prolonged in human compared with mouse, resulting in human motor neuron differentiation taking about 2.5 times longer than mouse. Differences in tempo were not due to differences in the sensitivity of cells to signals, nor could they be attributed to differences in the sequence of the key genes or their regulatory elements. Instead, the data revealed that changes in protein stability correlated with developmental tempo, such that slower temporal progression in human corresponded to increased protein stability. An in silico model indicated that increased protein stability could account for the slower tempo of development in human compared with mouse.

The results suggest that differences in protein turnover play a role in interspecies differences in the pace of motor neuron differentiation. The identification of a molecular mechanism that can explain differences in the pace of embryonic development between species focuses attention on the role of protein stability in tempo control. This suggests a parsimonious explanation for the substantial variation in the tempo of development between species and indicates how the overall dynamics of developmental processes can be influenced by kinetic properties of gene regulation. What determines species-specific rates of protein turnover remains to be determined, but the availability of in vitro systems that mimic in vivo developmental tempo opens up the possibility of exploring this issue.

Different animal species develop at different tempos, and equivalent developmental stages can be matched between mouse and human at different developmental time points. Neural progenitors in the spinal cord progress through the same succession of gene expression to generate motor neurons in mouse and human, and this serves as a model to study tempo differences. The in vitro directed differentiation of mouse embryonic stem cells to motor neurons advances at greater than twice the speed of human embryonic stem cell differentiation. The equivalent progression of development at different rates is shown for the transcription factors PAX6 (green), OLIG2 (red), and NKX2.2 (blue). E, embryonic day; W, embryonic week; CS, Carnegie stage. Scale bars are 50 m.

Although many molecular mechanisms controlling developmental processes are evolutionarily conserved, the speed at which the embryo develops can vary substantially between species. For example, the same genetic program, comprising sequential changes in transcriptional states, governs the differentiation of motor neurons in mouse and human, but the tempo at which it operates differs between species. Using in vitro directed differentiation of embryonic stem cells to motor neurons, we show that the program runs more than twice as fast in mouse as in human. This is not due to differences in signaling, nor the genomic sequence of genes or their regulatory elements. Instead, there is an approximately two-fold increase in protein stability and cell cycle duration in human cells compared with mouse cells. This can account for the slower pace of human development and suggests that differences in protein turnover play a role in interspecies differences in developmental tempo.

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AgeX Therapeutics and Lineage Cell Therapeutics Announce Expansion of Agreement Related to ESI Clinical-grade Pluripotent Stem Cell Lines for…

By daniellenierenberg

Sept. 9, 2020 12:00 UTC

ALAMEDA, Calif. & CARLSBAD, Calif.--(BUSINESS WIRE)-- AgeX Therapeutics, Inc.(AgeX: NYSE American: AGE), a company focused on developing and commercializing innovative therapeutics for human aging, and Lineage Cell Therapeutics, Inc.. (Lineage: NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, and ES Cell International Pte Ltd. (ESI), a subsidiary of Lineage, today announced the broadening of their collaborative relationship with regard to ESI stem cell lines. ESI cell lines are current Good Manufacturing Practice (cGMP)-compatible, registered with the National Institutes of Health (NIH), and widely studied as a potential source for the industrial-scale manufacture of any cell type in the human body. Neither party made or received any cash payments in connection with this arrangement.

Both Lineage and AgeX are pioneering important aspects of regenerative medicine. Working together, we have amended our agreement regarding ESI cell lines derived under cGMP to be optimal for the business needs of each company, stated Brian M. Culley, Lineages CEO. In particular, Lineage has acquired exclusivity for the use of ESI cell lines in spinal cord injury and certain oncology indications. On the other hand, AgeX has gained greater flexibility and independence to support its efforts toward licensing certain technologies and cell lines to third parties. With this step complete, we next intend to explore additional opportunities to collaborate with AgeX on promising tissue regenerating projects.

The ESI cell lines are recognized for being the first clinical-grade human pluripotent stem cell lines created under cGMP as described in the publication Cell Stem Cell (2007;1:490-4). It may become possible to generate potentially limitless quantities of all the cell types of the human body from these master cell banks with a wide array of potential therapeutic applications. These cell lines are listed on the NIH Stem Cell Registry and are among the best characterized and documented stem cell lines available globally. Importantly, ESI cells are among only a few pluripotent stem cell lines from which a derived cell therapy product candidate has been granted FDA investigational new drug (IND) clearance to commence human studies.

Key to the creation of shareholder value is the placement of these important assets in the hands of collaborators to advance the development of a vast number of regenerative therapies, said Michael West, Ph.D., AgeXs CEO. Our collaborative relationship with Lineage led to this streamlined process that may facilitate the commercialization of these applications to the benefit of shareholders of each company. Since the beginning of the year, AgeX has entered into new research and commercial arrangements utilizing an array of its technology platforms, such as UniverCyteTM for the engineering of universally transplantable cells, PureStem for the manufacture and derivation of cells, and an ESI cell line as source material for deriving cellular therapeutics.

About AgeX Therapeutics, Inc

AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on developing and commercializing innovative therapeutics for human aging. Its PureStem and UniverCyte manufacturing and immunotolerance technologies are designed to work together to generate highly defined, universal, allogeneic, off-the-shelf pluripotent stem cell-derived young cells of any type for application in a variety of diseases with a high unmet medical need. AgeX has two preclinical cell therapy programs: AGEX-VASC1 (vascular progenitor cells) for tissue ischemia and AGEX-BAT1 (brown fat cells) for Type II diabetes. AgeXs revolutionary longevity platform induced Tissue Regeneration (iTR) aims to unlock cellular immortality and regenerative capacity to reverse age-related changes within tissues. AGEX-iTR1547 is an iTR-based formulation in preclinical development. HyStem is AgeXs delivery technology to stably engraft PureStem cell therapies in the body. AgeXs core product pipeline is intended to extend human healthspan. AgeX is seeking opportunities to establish licensing and collaboration arrangements around its broad IP estate and proprietary technology platforms and therapy product candidates. For more information, please visit http://www.agexinc.com or connect with the company on Twitter, LinkedIn, Facebook, and YouTube.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineages programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineages clinical programs are in markets with billion dollar opportunities and include three allogeneic (off-the-shelf) product candidates: (i) OpRegen, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer and in preclinical development for additional cancers and as a vaccine against infectious diseases, including SARS-CoV-2, the virus which causes COVID-19. For more information, please visit http://www.lineagecell.com or follow the Company on Twitter @LineageCell.

About ESI

ES Cell International Pte Ltd (ESI). Established in 2000, ESI, a wholly owned subsidiary of Lineage Cell Therapeutics, Inc., developed ESI hESC lines in compliance with the principles of current Good Manufacturing Practices and has made them available to various biopharmaceutical companies, universities and other research institutions, including AgeX. These ESI cell lines are extensively characterized and most of the lines have documented and publicly available genomic sequences.

Forward-Looking Statements for AgeX

Certain statements contained in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not historical fact including, but not limited to statements that contain words such as will, believes, plans, anticipates, expects, estimates should also be considered forward-looking statements. Forward-looking statements involve risks and uncertainties. Without limitation, such risks include those associated with the use of human pluripotent stem cell lines in the research, development, and use of therapies for the treatment of human diseases, disorders, and injuries, and risks associated with commercializing the pluripotent stem cell lines. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of AgeX Therapeutics, Inc. and its respective subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the Risk Factors section of its most recent Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commissions (copies of which may be obtained at http://www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. Undue reliance should not be placed on forward-looking statements, which speak only as of the date on which they were made. AgeX specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

Forward-Looking Statements for Lineage

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as believe, may, will, estimate, continue, anticipate, design, intend, expect, could, plan, potential, predict, seek, should, would, contemplate, project, target, tend to, or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to the potential commercialization of ESI cell lines. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineages actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineages business and other risks in Lineages filings with the Securities and Exchange Commission (the SEC). Lineages forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading Risk Factors in Lineages periodic reports with the SEC, including Lineages Annual Report on Form 10-K filed with the SEC on March 12, 2020 and its other reports, which are available from the SECs website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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AgeX Therapeutics and Lineage Cell Therapeutics Announce Expansion of Agreement Related to ESI Clinical-grade Pluripotent Stem Cell Lines for...

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Lineage Cell Therapeutics : AgeX Therapeutics and Lineage Cell Therapeutics Announce Expansion of Agreement Related to ESI Clinical-grade Pluripotent…

By daniellenierenberg

AgeX Therapeutics, Inc. (AgeX: NYSE American: AGE), a company focused on developing and commercializing innovative therapeutics for human aging, and Lineage Cell Therapeutics, Inc. (Lineage: NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, and ES Cell International Pte Ltd. (ESI), a subsidiary of Lineage, today announced the broadening of their collaborative relationship with regard to ESI stem cell lines. ESI cell lines are current Good Manufacturing Practice (cGMP)-compatible, registered with the National Institutes of Health (NIH), and widely studied as a potential source for the industrial-scale manufacture of any cell type in the human body. Neither party made or received any cash payments in connection with this arrangement.

Both Lineage and AgeX are pioneering important aspects of regenerative medicine. Working together, we have amended our agreement regarding ESI cell lines derived under cGMP to be optimal for the business needs of each company, stated Brian M. Culley, Lineages CEO. In particular, Lineage has acquired exclusivity for the use of ESI cell lines in spinal cord injury and certain oncology indications. On the other hand, AgeX has gained greater flexibility and independence to support its efforts toward licensing certain technologies and cell lines to third parties. With this step complete, we next intend to explore additional opportunities to collaborate with AgeX on promising tissue regenerating projects.

The ESI cell lines are recognized for being the first clinical-grade human pluripotent stem cell lines created under cGMP as described in the publication Cell Stem Cell (2007;1:490-4). It may become possible to generate potentially limitless quantities of all the cell types of the human body from these master cell banks with a wide array of potential therapeutic applications. These cell lines are listed on the NIH Stem Cell Registry and are among the best characterized and documented stem cell lines available globally. Importantly, ESI cells are among only a few pluripotent stem cell lines from which a derived cell therapy product candidate has been granted FDA investigational new drug (IND) clearance to commence human studies.

Key to the creation of shareholder value is the placement of these important assets in the hands of collaborators to advance the development of a vast number of regenerative therapies, said Michael West, Ph.D., AgeXs CEO. Our collaborative relationship with Lineage led to this streamlined process that may facilitate the commercialization of these applications to the benefit of shareholders of each company. Since the beginning of the year, AgeX has entered into new research and commercial arrangements utilizing an array of its technology platforms, such as UniverCyteTM for the engineering of universally transplantable cells, PureStem for the manufacture and derivation of cells, and an ESI cell line as source material for deriving cellular therapeutics.

About AgeX Therapeutics, Inc

AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on developing and commercializing innovative therapeutics for human aging. Its PureStem and UniverCyte manufacturing and immunotolerance technologies are designed to work together to generate highly defined, universal, allogeneic, off-the-shelf pluripotent stem cell-derived young cells of any type for application in a variety of diseases with a high unmet medical need. AgeX has two preclinical cell therapy programs: AGEX-VASC1 (vascular progenitor cells) for tissue ischemia and AGEX-BAT1 (brown fat cells) for Type II diabetes. AgeXs revolutionary longevity platform induced Tissue Regeneration (iTR) aims to unlock cellular immortality and regenerative capacity to reverse age-related changes within tissues. AGEX-iTR1547 is an iTR-based formulation in preclinical development. HyStem is AgeXs delivery technology to stably engraft PureStem cell therapies in the body. AgeXs core product pipeline is intended to extend human healthspan. AgeX is seeking opportunities to establish licensing and collaboration arrangements around its broad IP estate and proprietary technology platforms and therapy product candidates. For more information, please visit http://www.agexinc.com or connect with the company on Twitter, LinkedIn, Facebook, and YouTube.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineages programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineages clinical programs are in markets with billion dollar opportunities and include three allogeneic (off-the-shelf) product candidates: (i) OpRegen, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer and in preclinical development for additional cancers and as a vaccine against infectious diseases, including SARS-CoV-2, the virus which causes COVID-19. For more information, please visit http://www.lineagecell.com or follow the Company on Twitter @LineageCell.

About ESI

ES Cell International Pte Ltd (ESI). Established in 2000, ESI, a wholly owned subsidiary of Lineage Cell Therapeutics, Inc., developed ESI hESC lines in compliance with the principles of current Good Manufacturing Practices and has made them available to various biopharmaceutical companies, universities and other research institutions, including AgeX. These ESI cell lines are extensively characterized and most of the lines have documented and publicly available genomic sequences.

Forward-Looking Statements for AgeX

Certain statements contained in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not historical fact including, but not limited to statements that contain words such as will, believes, plans, anticipates, expects, estimates should also be considered forward-looking statements. Forward-looking statements involve risks and uncertainties. Without limitation, such risks include those associated with the use of human pluripotent stem cell lines in the research, development, and use of therapies for the treatment of human diseases, disorders, and injuries, and risks associated with commercializing the pluripotent stem cell lines. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of AgeX Therapeutics, Inc. and its respective subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the Risk Factors section of its most recent Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commissions (copies of which may be obtained at http://www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. Undue reliance should not be placed on forward-looking statements, which speak only as of the date on which they were made. AgeX specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

Forward-Looking Statements for Lineage

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as believe, may, will, estimate, continue, anticipate, design, intend, expect, could, plan, potential, predict, seek, should, would, contemplate, project, target, tend to, or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to the potential commercialization of ESI cell lines. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineages actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineages business and other risks in Lineages filings with the Securities and Exchange Commission (the SEC). Lineages forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading Risk Factors in Lineages periodic reports with the SEC, including Lineages Annual Report on Form 10-K filed with the SEC on March 12, 2020 and its other reports, which are available from the SECs website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200909005398/en/

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Global Cord Blood Banking Market 2020 with Analysis of 44 Industry Players – PRNewswire

By daniellenierenberg

DUBLIN, Sept. 2, 2020 /PRNewswire/ -- The "Global Cord Blood Banking Industry Report 2020" report has been added to ResearchAndMarkets.com's offering.

This report presents the number of cord blood units stored in inventory by the largest cord blood banks worldwide and the number of cord blood units (CBUs) released by registries across the world for hematopoietic stem cell (HSC) transplantation. Although cord blood is now used to treat more than 80 different diseases, this number could substantially expand if applications related to regenerative medicine start receiving approvals in major healthcare markets worldwide.

From the early 1900s through the mid-2000s, the global cord blood banking industry expanded rapidly, with companies opening for business in all major markets worldwide. From 2005 to 2010, the market reached saturation and stabilized.

Then, from 2010 to 2020, the market began to aggressively consolidate. This has created both serious threats and unique opportunities within the industry.

Serious threats to the industry include low rates of utilization for stored cord blood, expensive cord blood transplantation procedures, difficulty educating obstetricians about cellular therapies, and an increasing trend toward industry consolidation. There are also emerging opportunities for the industry, such as accelerated regulatory pathways for cell therapies in leading healthcare markets worldwide and expanding applications for cell-based therapies. In particular, MSCs from cord tissue (and other sources) are showing intriguing promise in the treatment and management of COVID-19.

Cord Blood Industry Trends

Within recent years, new themes have been impacting the industry, including the pairing of stem cell storage services with genetic and genomic testing services, as well as reproductive health services. Cord blood banks are diversifying into new types of stem cell storage, including umbilical cord tissue storage, placental blood and tissue, amniotic fluid and tissue, and dental pulp. Cord blood banks are also investigating means of becoming integrated therapeutic companies. With hundreds of companies offering cord blood banking services worldwide, maturation of the market means that each company is fighting harder for market share.

Growing numbers of investors are also entering the marketplace, with M&A activity accelerating in the U.S. and abroad. Holding companies are emerging as a global theme, allowing for increased operational efficiency and economy of scale. Cryoholdco has established itself as the market leader within Latin America. Created in 2015, Cryoholdco is a holding company that will control nearly 270,000 stem cell units by the end of 2020. It now owns a half dozen cord blood banks, as well as a dental stem cell storage company.

Globally, networks of cord blood banks have become commonplace, with Sanpower Group establishing its dominance in Asia. Although Sanpower has been quiet about its operations, it holds 4 licenses out of only 7 issued provincial-level cord blood bank licenses in China. It has reserved over 900,000 cord blood samples in China, and its reserves amount to over 1.2 million units when Cordlife' reserves within Southeast Asian countries are included. This positions Sanpower Group and it's subsidiary Nanjing Cenbest as the world's largest cord blood banking operator not only in China and Southeast Asia but in the world.

The number of cord blood banks in Europe has dropped by more than one-third over the past ten years, from approximately 150 to under 100. The industry leaders in this market segment include FamiCord Group, who has executed a dozen M&A transactions, and Vita34, who has executed approximately a half dozen. Stemlab, the largest cord blood bank in Portugal, also executed three acquisition deals prior to being acquired by FamiCord. FamiCord is now the leading stem cell bank in Europe and one of the largest worldwide.

Cord Blood Expansion Technologies

Because cord blood utilization is largely limited to use in pediatric patients, growing investment is flowing into ex vivo cord blood expansion technologies. If successful, this technology could greatly expand the market potential for cord blood, encouraging its use within new markets, such as regenerative medicine, aging, and augmented immunity.

Key strategies being explored for this purpose include:

Currently, Gamida Cell, Nohla Therapeutics, Excellthera, and Magenta Therapeutics have ex vivo cord blood expansion products proceeding through clinical trials. Growing numbers of investors have also entered the cord blood banking marketplace, led by groups such as GI Partners, ABS Capital Partners & HLM Management, KKR & Company, Bay City Capital, GTCR, LLC, and Excalibur.

Cord Blood Banking by Region

Within the United States, most of the market share is controlled by three major players: Cord Blood Registry (CBR), Cryo-Cell, and ViaCord. CBR has been traded twice, once in 2015 to AMAG Pharmaceuticals for $700 million and again in 2018 to GI Partners for $530 million. CBR also bought Natera's Evercord Cord Blood Banking business in September 2019. In total, CBR controls over 900,000 cord blood and tissue samples, making it one of the largest cord blood banks worldwide.

In China, the government controls the industry by authorizing only one cord blood bank to operate within each province, and official government support, authorization, and permits are required. Importantly, the Chinese government announced in late 2019 that it will be issuing new licenses for the first time, expanding from the current 7 licensed regions for cord blood banking to up to 19 regions, including Beijing.

In Italy and France, it is illegal to privately store one's cord blood, which has fully eliminated the potential for a private market to exist within the region. In Ecuador, the government created the first public cord blood bank and instituted laws such that private cord blood banks cannot approach women about private cord blood banking options during the first six months of pregnancy. This created a crisis for private banks, forcing most out of business.

Recently, India's Central Drugs Standard Control Organization (CDSCO) restricted commercial banking of stem cells from most biological materials, including cord tissue, placenta, and dental pulp stem cells - leaving only umbilical cord blood banking as permitted and licensed within the country.

While market factors vary by geography, it is crucial to have a global understanding of the industry, because research advances, clinical trial findings, and technology advances do not know international boundaries. The cord blood market is global in nature and understanding dynamics within your region is not sufficient for making strategic, informed, and profitable decisions.

Overall, the report provides the reader with the following details and answers the following questions:

1. Number of cord blood units cryopreserved in public and private cord blood banks globally2. Number of hematopoietic stem cell transplants (HSCTs) globally using cord blood cells3. Utilization of cord blood cells in clinical trials for developing regenerative medicines4. The decline of the utilization of cord blood cells in HSC transplantations since 20055. Emerging technologies to influence the financial sustainability of public cord blood banks6. The future scope for companion products from cord blood7. The changing landscape of cord blood cell banking market8. Extension of services by cord blood banks9. Types of cord blood banks10. The economic model of public cord blood banks11. Cost analysis for public cord blood banks12. The economic model of private cord blood banks13. Cost analysis for private cord blood banks14. Profit margins for private cord blood banks15. Pricing for processing and storage in private banks16. Rate per cord blood unit in the U.S. and Europe17. Indications for the use of cord blood-derived HSCs for transplantations18. Diseases targeted by cord blood-derived MSCs in regenerative medicine19. Cord blood processing technologies20. Number of clinical trials, number of published scientific papers and NIH funding for cord blood research21. Transplantation data from different cord blood registries

Key questions answered in this report are:

1. What are the strategies being considered for improving the financial stability of public cord blood banks?2. What are the companion products proposed to be developed from cord blood?3. How much is being spent on processing and storing a unit of cord blood?4. How much does a unit of cryopreserved cord blood unit fetch on release?5. Why do most public cord blood banks incur a loss?6. What is the net profit margin for a private cord blood bank?7. What are the prices for processing and storage of cord blood in private cord blood banks?8. What are the rates per cord blood units in the U.S. and Europe?9. What are the revenues from cord blood sales for major cord blood banks?10. Which are the different accreditation systems for cord blood banks?11. What are the comparative merits of the various cord blood processing technologies?12. What is to be done to increase the rate of utilization of cord blood cells in transplantations?13. Which TNC counts are preferred for transplantation?14. What is the number of registered clinical trials using cord blood and cord tissue?15. How many clinical trials are involved in studying the expansion of cord blood cells in the laboratory?16. How many matching and mismatching transplantations using cord blood units are performed on an annual basis?17. What is the share of cord blood cells used for transplantation from 2000 to 2020?18. What is the likelihood of finding a matching allogeneic cord blood unit by ethnicity?19. Which are the top ten countries for donating cord blood?20. What are the diseases targeted by cord blood-derived MSCs within clinical trials?

Key Topics Covered

1. REPORT OVERVIEW1.1 Statement of the Report1.2 Executive Summary1.3 Introduction1.3.1 Cord Blood: An Alternative Source for HPSCs1.3.2 Utilization of Cord Blood Cells in Clinical Trials1.3.3 The Struggle of Cord Blood Banks1.3.4 Emerging Technologies to Influence Financial Sustainability of Banks1.3.4.1 Other Opportunities to Improve Financial Stability1.3.4.2 Scope for Companion Products1.3.5 Changing Landscape of Cord Blood Cell Banking Market1.3.6 Extension of Services by Cord Blood Banks

2. CORD BLOOD & CORD BLOOD BANKING: AN OVERVIEW2.1 Cord Blood Banking (Stem Cell Banking)2.1.1 Public Cord Blood Banks2.1.1.1 Economic Model of Public Cord Blood Banks2.1.1.2 Cost Analysis for Public Banks2.1.1.3 Relationship between Costs and Release Rates2.1.2 Private Cord Blood Banks2.1.2.1 Cost Analysis for Private Cord Blood Banks2.1.2.2 Economic Model of Private Banks2.1.3 Hybrid Cord Blood Banks2.2 Globally Known Cord Blood Banks2.2.1 Comparing Cord Blood Banks2.2.2 Cord Blood Banks in the U.S.2.2.3 Proportion of Public, Private and Hybrid Banks2.3 Percent Share of Parents of Newborns Storing Cord Blood by Country/Region2.4 Pricing for Processing and Storage in Commercial Banks2.4.1 Rate per Cord Blood Unit in the U.S. and Europe2.5 Cord Blood Revenues for Major Cord Blood Banks

3. CORD BLOOD BANK ACCREDITATIONS3.1 American Association of Blood Banks (AABB)3.2 Foundation for the Accreditation of Cellular Therapy (FACT)3.3 FDA Registration3.4 FDA Biologics License Application (BLA) License3.5 Investigational New Drug (IND) for Cord Blood3.6 Human Tissue Authority (HTA)3.7 Therapeutic Goods Act (TGA) in Australia3.8 International NetCord Foundation3.9 AABB Accredited Cord Blood Facilities3.10 FACT Accreditation for Cord Blood Banks

4. APPLICATIONS OF CORD BLOOD CELLS4.1 Hematopoietic Stem Cell Transplantations with Cord Blood Cells4.2 Cord Cells in Regenerative Medicine

5. CORD BLOOD PROCESSING TECHNOLOGIES5.1 The Process of Separation5.1.1 PrepaCyte-CB5.1.2 Advantages of PrepaCyte-CB5.1.3 Treatment Outcomes with PrepaCyte-CB5.1.4 Hetastarch (HES)5.1.5 AutoXpress (AXP)5.1.6 SEPAX5.1.7 Plasma Depletion Method (MaxCell Process)5.1.8 Density Gradient Method5.2 Comparative Merits of Different Processing Methods5.2.1 Early Stage HSC Recovery by Technologies5.2.2 Mid Stage HSC (CD34+/CD133+) Recovery from Cord Blood5.2.3 Late Stage Recovery of HSCs from Cord Blood5.3 HSC (CD45+) Recovery5.4 Days to Neutrophil Engraftment by Technology5.5 Anticoagulants used in Cord Blood Processing5.5.1 Type of Anticoagulant and Cell Recovery Volume5.5.2 Percent Cell Recovery by Sample Size5.5.3 TNC Viability by Time Taken for Transport and Type of Anticoagulant5.6 Cryopreservation of Cord Blood Cells5.7 Bioprocessing of Umbilical Cord Tissue (UCT)5.8 A Proposal to Improve the Utilization Rate of Banked Cord Blood

6. CORD BLOOD CLINICAL TRIALS, SCIENTIFIC PUBLICATIONS & NIH FUNDING6.1 Cord Blood Cells for Research6.2 Cord Blood Cells for Clinical Trials6.2.1 Number of Clinical Trials involving Cord Blood Cells6.2.2 Number of Clinical Trials using Cord Blood Cells by Geography6.2.3 Number of Clinical Trials by Study Type6.2.4 Number of Clinical Trials by Study Phase6.2.5 Number of Clinical Trials by Funder Type6.2.6 Clinical Trials Addressing Indications in Children6.2.7 Select Three Clinical Trials Involving Children6.2.7.1 Sensorineural Hearing Loss (NCT02038972)6.2.7.2 Autism Spectrum (NCT02847182)6.2.7.3 Cerebral Palsy (NCT01147653)6.2.8 Clinical Trials for Neurological Diseases using Cord Blood and Cord Tissue6.2.9 UCB for Diabetes6.2.10 UCB in Cardiovascular Clinical Trials6.2.11 Cord Blood Cells for Auto-Immune Diseases in Clinical Trials6.2.12 Cord Tissue Cells for Orthopedic Disorders in Clinical Trials6.2.13 Cord Blood Cells for Other Indications in Clinical Trials6.3 Major Diseases Addressed by Cord Blood Cells in Clinical Trials6.4 Clinical Trials using Cord Tissue-Derived MSCs6.5 Ongoing Clinical Trials using Cord Tissue6.5.1 Cord Tissue-Based Clinical Trials by Geography6.5.2 Cord Tissue-Based Clinical Trials by Phase6.5.3 Cord Tissue-Based Clinical Trials by Sponsor Types6.5.4 Companies Sponsoring in Trials using Cord Tissue-Derived MSCs6.6 Wharton's Jelly-Derived MSCs in Clinical Trials6.6.1 Wharton's Jelly-Based Clinical Trials by Phase6.6.2 Companies Sponsoring Wharton's Jelly-Based Clinical Trials6.7 Clinical Trials Involving Cord Blood Expansion Studies6.7.1 Safe and Feasible Expansion Protocols6.7.2 List of Clinical Trials involved in the Expansion of Cord Blood HSCs6.7.3 Expansion Technologies6.8 Scientific Publications on Cord Blood6.9 Scientific Publications on Cord Tissue6.10 Scientific Publications on Wharton's Jelly-Derived MSCs6.11 Published Scientific Papers on Cord Blood Cell Expansion6.12 NIH Funding for Cord Blood Research

7. PARENT'S AWARENESS AND ATTITUDE TOWARDS CORD BLOOD BANKING7.1 Undecided Expectant Parents7.2 The Familiar Cord Blood Banks Known by the Expectant Parents7.3 Factors Influencing the Choice of a Cord Blood Bank

8. CORD BLOOD: AS A TRANSPLANTATION MEDICINE8.1 Comparisons of Cord Blood to other Allograft Sources8.1.1 Major Indications for HCTs in the U.S.8.1.2 Trend in Allogeneic HCT in the U.S. by Recipient Age8.1.3 Trends in Autologous HCT in the U.S. by Recipient Age8.2 HCTs by Cell Source in Adult Patients8.2.1 Transplants by Cell Source in Pediatric Patients8.3 Allogeneic HCTs by Cell Source8.3.1 Unrelated Donor Allogeneic HCTs in Patients &lessThan;18 Years8.4 Likelihood of Finding an Unrelated Cord Blood Unit by Ethnicity8.4.1 Likelihood of Finding an Unrelated Cord Blood Unit for Patients &lessThan;20 Years8.5 Odds of using a Baby's Cord Blood8.6 Cord Blood Utilization Trends8.7 Number of Cord Blood Donors Worldwide8.7.1 Number of CBUs Stored Worldwide8.7.2 Cord Blood Donors by Geography8.7.2.1 Cord Blood Units Stored in Different Geographies8.7.2.2 Number of Donors by HLA Typing8.7.3 Searches Made by Transplant Patients for Donors/CBUs8.7.4 Types of CBU Shipments (Single/Double/Multi)8.7.5 TNC Count of CBUs Shipped for Children and Adult Patients8.7.6 Shipment of Multiple CBUs8.7.7 Percent Supply of CBUs for National and International Patients8.7.8 Decreasing Number of CBU Utilization8.8 Top Ten Countries in Cord Blood Donation8.8.1 HLA Typed CBUs by Continent8.8.2 Percentage TNC of Banked CBUs8.8.3 Total Number of CBUs, HLA-Typed Units by Country8.9 Cord Blood Export/Import by the E.U. Member States8.9.1 Number of Donors and CBUs in Europe8.9.2 Number of Exports/Imports of CBUs in E.U.8.10 Global Exchange of Cord Blood Units

9. CORD BLOOD CELLS AS THERAPEUTIC CELL PRODUCTS IN CELL THERAPY9.1 MSCs from Cord Blood and Cord Tissue9.1.1 Potential Neurological Applications of Cord Blood-Derived Cells9.1.2 Cord Tissue-Derived MSCs for Therapeutic use9.1.2.1 Indications Targeted by UCT-MSCs in Clinical Trials9.2 Current Consumption of Cord Blood Units by Clinical Trials9.3 Select Cord Blood Stem Cell Treatments in Clinical Trials9.3.1 Acquired Hearing Loss (NCT02038972)9.3.2 Autism (NCT02847182)9.3.3 Cerebral Palsy (NCT03087110)9.3.4 Hypoplastic Left Heart Syndrome (NCT01856049)9.3.5 Type 1 Diabetes (NCT00989547)9.3.6 Psoriasis (NCT03765957)9.3.7 Parkinson's Disease (NCT03550183)9.3.8 Signs of Aging (NCT04174898)9.3.9 Stroke (NCT02433509)9.3.10 Traumatic Brain Injury (NCT01451528)

10. MARKET ANALYSIS10.1 Public vs. Private Cord Blood Banking Market10.2 Cord Blood Banking Market by Indication

11. PROFILES OF SELECT CORD BLOOD BANKS11.1 AllCells11.1.1 Whole Blood11.1.2 Leukopak11.1.3 Mobilized Leukopak11.1.4 Bone Marrow11.1.5 Cord Blood11.2 AlphaCord LLC11.2.1 NextGen Collection System11.3 Americord Registry, Inc.11.3.1 Cord Blood 2.011.3.2 Cord Tissue11.3.3 Placental Tissue 2.011.4 Be The Match11.4.1 Hub of Transplant Network11.4.2 Partners of Be The Match11.4.3 Allogeneic Cell Sources in Be The Match Registry11.4.4 Likelihood of a Matched Donor on Be The Match by Ethnic Background11.5 Biocell Center Corporation11.5.1 Chorionic villi after Delivery11.5.2 Amniotic Fluid and Chorionic Villi during Pregnancy11.6 BioEden Group, Inc.11.6.1 Differences between Tooth Cells and Umbilical Cord Cells11.7 Biovault Family11.7.1 Personalized Cord Blood Processing11.8 Cell Care11.9 Cells4Life Group, LLP11.9.1 Cells4Life's pricing11.9.2 TotiCyte Technology11.9.3 Cord Blood Releases11.10 Cell-Save11.11 Center for International Blood and Marrow Transplant Research (CIBMTR)11.11.1 Global Collaboration11.11.2 Scientific Working Committees11.11.3 Medicare Clinical Trials and Studies11.11.4 Cellular Therapy11.12 Crio-Cell International, Inc.11.12.1 Advanced Collection Kit11.12.2 Prepacyte-CB11.12.3 Crio-Cell International's Pricing11.12.4 Revenue for Crio-Cell International11.13 Cord Blood Center Group11.13.1 Cord Blood Units Released11.14 Cordlife Group, Ltd.11.14.1 Cordlife's Cord Blood Release Track Record11.15 Core23 Biobank11.16 Cord Blood Registry (CBR)11.17 CordVida11.18 Crioestaminal11.18.1 Cord Blood Transplantation in Portugal11.19 Cryo-Cell International, Inc.11.19.1 Processing Method11.19.2 Financial Results of the Company11.20 CryoHoldco11.21 Cryoviva Biotech Pvt. Ltd11.22 European Society for Blood and Bone Marrow Transplantation (EBMT)11.22.1 EBMT Transplant Activity11.23 FamiCord Group11.24 GeneCell International11.25 Global Cord Blood Corporation11.25.1 The Company's Business11.26 HealthBaby Hong Kong11.26.1 BioArchive System Service Plan11.26.2 MVE Liquid Nitrogen System11.27 HEMAFUND11.28 Insception Lifebank11.29 LifebankUSA11.29.1 Placental Banking11.30 LifeCell International Pvt. Ltd.11.31 MiracleCord, Inc.11.32 Maze Cord Blood Laboratories11.33 New England Cord Blood Bank, Inc.11.34 New York Cord Blood Center (NYBC)11.34.1 Products11.34.2 Laboratory Services11.35 PacifiCord11.35.1 FDA-Approved Sterile Collection Bags11.35.2 AXP Processing System11.35.3 BioArchive System11.36 ReeLabs Pvt. Ltd.11.37 Smart Cells International, Ltd.11.38 Stem Cell Cryobank11.39 StemCyte, Inc.11.39.1 StemCyte Sponsored Clinical Trials11.39.1.1 Spinal Cord Injury Phase II11.39.1.2 Other Trials11.40 Transcell Biolife11.40.1 ScellCare11.40.2 ToothScell11.41 ViaCord11.42 Vita 34 AG11.43 World Marrow Donor Association (WMDA)11.43.1 Search & Match Service11.44 Worldwide Network for Blood & Marrow Transplantation (WBMT)

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Global Cord Blood Banking Market 2020 with Analysis of 44 Industry Players - PRNewswire

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Royal Biologics Announces the Acquisition of FIBRINET – PRNewswire

By daniellenierenberg

HACKENSACK, N.J., Sept. 1, 2020 /PRNewswire/ --Royal Biologics, an ortho-biologics company specializing in the research and advancement of autologous and live cellular solutions, today announced the completed acquisition of FIBRINET, from Vertical Spine LLC. The acquisition comes as part of Royal Biologics' strategic initiative to add novel technologies to its growing portfolio of autologous and live cellular solutions to support orthopedic and spinal fusion.

The FIBRINET system utilizes a patient's own autologous blood to create a platelet-rich fibrin matrix/membrane (PRFM). During this process, a patient's autologous platelets are harvested first through centrifugation and then combined with a proprietary solution to solidify into a fibrin clot/membrane. PRFM can be used to help augment spinal fusions and provide surgeons a new and novel biologic option. FIBRINET is the first commercialized system that utilizes a non-thrombin solution to create a reproducible platelet-rich fibrin matrix. The use of its proprietary solution to solidify a fibrin membrane provides the unique advantage of creating a biologic reservoir of growth factors and stem cells that can be held and used at the point of care for spinal fusion.

"We are extremely excited to add FIBRINET to our growing portfolio of autologous and live cellular therapies," says Salvatore Leo, Royal Biologics Chief Executive Officer. "FIBRINET'S technology now allows surgeons to harvest a patient's autologous cells and create a unique platelet-rich fibrin membrane-scaffold to be used at the point of care in most spinal fusion procedures. When added to our current product portfolio of autologous and live cellular therapies, we feel that providing each patient an opportunity to harvest their own unique cells for treatment is a superior option in many surgical settings."

FIBRINET has shown promising results and has been adopted into major orthopedic institutions in the United States. Hospitals such as Hospital for Special Surgery, Mount Sinai, NY Presbyterian and Connecticut's Orthopaedic Institute have all adopted FIBRINET into their spine services portfolio of approved products for use.

In a recent European Spine Journalstudy, at a one-year follow-up, FIBRINET demonstrated over a 92.4% radiographic fusion, and there was a significant improvement recorded in VAS scores for both back and leg pain. Compared to baseline figures, the number of patients using opioid analgesics at 12 months decreased by 38%. While the majority (31/50) of patients that participated in the study were retired, 68% of the employed patients were able to return to work.1

"FIBRINET presents itself as a low-cost option to obtain premium, high-quality viable cells from the patient for each fusion procedure," comments Dr. James Yue, Co-Chief and Orthopedic Spine Surgeon at Midstate Medical Center. "During this pandemic, a time when patients are having difficulty receiving operations in major hospital systems, the transition of procedures to ambulatory surgery centers has become even more desired and essential. FIBRINET's low-cost bundle provides surgeons the ability to offer a live viable cell product, point of care in a streamlined and safe environment for spinal fusion."

As part of a national re-launch plan for FIBRINET, Royal Biologics has just launched a new 3D animated moviethat demonstrates the unique features and benefits of FIBRINET's technology. "We wanted to show surgeons, distributors and our peers a new and creative take on Autologous & Live Cellular therapy," comments Leo. "With the recent pandemic and industry environment, we felt it was necessary to help create a unique viewing experience of the FIBRINET system."

FIBRINET comes after two other recent product launches from Royal Biologics in Q1 of 2020. Magnus, a live viable cellular allograft, and Cryo-Cord, a live cellular umbilical cord, were launched in the first quarter of 2020. Both products focus on providing live cellular therapies without the use of traditional toxic cyro-protectants. Both products are new, novel approaches to preserving live cells in a cryo-protected format.

Royal Biologic's FIBRINET is available for U.S. national distribution. Please contact [emailprotected] for more information.

1"Singlecenter, consecutive series study of the use of a novel plateletrich fibrin matrix (PRFM) and betatricalcium phosphate in posterolateral lumbar fusion," European Spine Journal https://doi.org/10.1007/s00586-018-5832-5, July 16, 2018.

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BrainStorm to present data linking MR measures to functional improvement in progressive multiple sclerosis – DOTmed HealthCare Business News

By daniellenierenberg

NEW YORK, Aug. 25, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today the acceptance of a clinical abstract documenting an association between magnetic resonance imaging (MRI) measures and functional improvement in patients with progressive multiple sclerosis (MS). The data, to be presented as a poster on September 11-13 at the forthcoming MSVirtual2020 meeting the eighth joint meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) will inform analysis of clinical outcomes in the Company's ongoing Phase 2 trial of NurOwn (MSC-NTF cells) in patients with progressive MS.

"Although disability improvement is an important measure of function in individuals with progressive MS, the MRI features that correlate with disability improvement had not previously been explored," noted Tanuja Chitnis, M.D., FAAN, Professor of Neurology at Harvard Medical School, Senior Neurologist at Brigham and Women's Hospital, and Director of the Comprehensive Longitudinal Investigations in MS at the Brigham (CLIMB Study). "In this analysis, we have demonstrated a correlation between specific brain and spinal cord MRI measures and observed functional improvements in progressive MS patients. We are grateful to the joint ACTRIMS/ECTRIMS abstract committee for allowing us to present these data, which we hope will facilitate analysis of clinical trial outcomes that specifically evaluate functional improvements in progressive MS."

Dr. Chitnis and colleagues evaluated MRI features of 48 participants in the SysteMS substudy of the CLIMB study, a nested cohort selected to match the inclusion criteria of the Phase 2 NurOwn trial in progressive MS (NCT03799718). The participants underwent brain and lesion volumetric analysis, as well as mean upper cervical cord (MUCCA) analysis, 12-24 months following baseline 3 Tesla MRI. These analyses generated 34 MRI data measures performed by ICOMETRIX, which the investigators compared in patients with improved function versus those with worsening or stable function, as measured by 9-hole peg test (9HPT) or timed-25-foot-walk (T25FW) scores, two well-established measures of function in progressive MS.

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AST-OPC1 Stem Cell Therapy Offers Hope for Spinal Cord Injury

By daniellenierenberg

An investigational treatment called AST-OPC1 (oligodendrocyte progenitor cells) may give new hope to people with a recent spinal cord injury. Researchers are examining whether AST-OPCI injected directly into the spinal cord helps repair damage in people with cervical (neck) spinal cord injury.

Researchers are examining whether AST-OPCI injected directly into the spinal cord helps repair damage in people with cervical (neck) spinal cord injury. Photo Source: 123RF.com.Until now, there have been no new treatment options for the 17,000 new spinal cord injuries that happen each year, said primary investigator Richard G. Fessler, MD, PhD, Professor of Neurological Surgery at Rush University Medical Center, Chicago, Illinois. We may be on the verge of making a major breakthrough after decades of attempts.

AST-OPC1 is developed from stem cells and is believed to work by supporting the proper functioning of nerve cells. After a spinal cord injury, many nerve cells are severed and beyond repair; however, many nerve cells have the potential to work again but have lost their protective coating (known as myelin) that helps nerves transfer messages to the arms and legs.

What AST-OPC1 does is recoat those potentially functional cells and allows them to work more normally, Dr. Fessler told SpineUniverse.

Left: Normal myelin sheath Right: Damaged myelin sheath. Photo Source: 123RF.com.

Dr. Fessler and colleagues are part of a larger multicenter trial designed to assess the safety and effectiveness of three doses of AST-OPC1 (2-, 10-, or 20-million cells) injected into the injured area of the spinal cord between 14 and 30 days following a cervical spinal cord injury. These individuals have essentially lost all sensation and movement below their injury site with severe paralysis of the arms and legs.

Thus far, Dr. Fessler and colleagues have injected three patients at the first dose level and five patients at the intermediate dose level.

Our preliminary results show that we may, in fact, be getting some regeneration. Some of those who have lost use of their hands are starting to get function back. That is the first time in history that has ever been done, Dr. Fessler said. The improvements are seen within the 30 to 60 days, he noted.

I have been doing this kind of research for more than 20 years, and Ive never seen anything as encouraging as AST-OPC1, Dr. Fessler said. Just as a journey of a thousand miles is done one step at a time, repairing spinal cord injuries is being done one step at a time. And, now, we can say that weve taken that first step.

The injections are safe, as determined by an earlier study of AST-OPC1 that involved patients with thoracic (mid-back) spinal cord injury. Dr. Fessler said it important for the spinal cord injury to be recent in order for the therapy to work. In addition, the spinal cord needs to be in continuity and not severed. The injections are unlikely to be effective in people who have had spinal cord injuries for years, although future trials are needed to know for sure.

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Stem Cells for Spinal Disorders – A Nonsurgical, Minimally …

By daniellenierenberg

The spinal column consists of 33 individual vertebrae with dozens of joints between them. Strong enough to withstand the rigors of daily wear and tear, but doing so decade after decade may be asking a lot. Deterioration can happen for a number of reasons - accidents, sports, hard labor, osteoarthritis, immune disorders, etc. Regardless of cause, sudden or gradual, the common denominator is usually severe pain.

There are 7 vertebrae in the cervical region which is your neck area, then 12 in the thoracic region which is your back, followed by 5 going down in the lumbar region or lower back, and another 5 in the sacral region and 4 in the coccygeal region which is technically your tail bone area. Any inflammation within these areas can potentially result in a domino-effect of radiating pain.

Any injury or disease involving the spine quickly affects mobility.Individuals unfortunate enough to be affected live in a world of perpetual hurt. The simple acts of sitting, walking, gripping, voiding, etc. can become cumbersome and daily reminders of injury.

The last ray of hope - surgery - has been shown to be ineffective in providing effective reprieve from symptoms in a significant proportion of patients.Whats more is that such invasive measures can prove to be a bigger setback than the pathology itself.

For the right patient, in the right context, minimally invasive stem cell therapies can change the course of many lives for the better.

What is Chronic Back and Neck pain?

Chronic back painis a broad term that pertains to inflammation, nerve impingement, degenerative disc damage and tissue breakdown in the spine. Such pain typically lasts 12 weeks or longer.

Neck pain is one of the most pervasive problems in the world today. Repetitive strain associated with most modern jobs is truly not kind to our necks. We spend a great deal of time viewing our screens at uncomfortable angles.Its no surprise that signs of osteoarthritis can be seen in 50% of the population of people over 50.

Spinal injuries of all types have the potential to make life a struggle for those living in its clutches. Depression is not uncommon as the stark reality of a completely altered quality of life sets in.

Relieving back and neck pain without surgery is now possible with new avenues in regenerative medicine - includingPlatelet-Rich Plasma (PRP), stem cell, and exosome therapies.

Advantages of these biological therapies over standard surgical options include their relative simplicity, the fact that they can be performed on an outpatient basis, are minimally invasive, can be done much faster, with fewer complications and a higher success rate in the right patient population. Biological therapies are ideal for patients between 20 and 70 years of age with mild to moderate disease burden.

Overview of Biological Therapies

Biological therapies (e.g. PRP, stem cell, exosome therapies) mark a new dawn in the field of healthcare.

The actual procedures involving such therapies are all pretty straightforward.With respect to PRP and stem cells, thecells are extracted from the patient, processed, and then administered back into the same patient at the intended target site. PRP is derived from peripheral blood, whereas stem cells can be obtained from bone marrow or one's own fat tissue.Stem cells may also be derived from a separate donor (e.g. umbilical cord).Exosomes are microscopic packets of instructions from one cell to another.In this instance, the exosomes are derived from donated stem cells and the message they're conveying is induction of tissue repair and regeneration at the target site.

Words of Caution

Important caveats include the following.When PRP science was in its infancy, providers would draw a patient's blood into a test tube similar to what you may be used to seeing at a commercial lab today.They would then isolate the PRP from that sample.It's important to note that regenerative medicine has progressed tremendously since those bygone days.A significant majority of clinics unfortunately continue to cling to the dated method of PRP processing despite much superior methods being available.

The main drivers for this inability to adapt has been that the newer methods are more skill intensive and costlier.To fully harness the benefits of PRP therapy, take the time research your provider and their methods.If blood collection tubes are used at any point in the procedure, it's a cheaper outdated method.If you're being offered "rock bottom prices," the quality of the procedure probably matches that price.

One of the biggest caveats regarding stem cells involves donated cells.Make sure the cells originate within the United States.Stateside labs are regulated by the Food and Drug Administration (FDA).As such, they have to abide by fairly strict standards of cleanliness and protocol.Clinics import cells from abroad easily and cheaply.However, you're truly rolling the dice when it comes to your health when you subject yourself to procedures at such clinics.

While on the topic of offshore stem cell therapy, prospective patients are often marketed a familiar line - "we can do special procedures at offshore sites that are disallowed by the FDA here in the states."Indeed clinics have garnered a supernatural aura about their methods through these marketing campaigns.As a consumer, you should understand that its generally a bad idea to trade world class health for third world health.More specifically, no credible data has been published to vouch for the effectiveness of these "too good to be legal" methods.

Such offshore arrangements protect the clinic in the event of gross negligence.The FDA is certainly stringent, but they also allow for legitimate avenues for pursuing investigational therapies.These clinics have opted to not pursue those processes as it's easier to find havens abroad where anything goes without repercussions.That's not to say success is impossible to get reasonable care at such sites, but if you lament a crosstown doctor's appointment, you might want to reconsider flying to a different country on short notice in the event of an unexpected post-procedural complication.

Finally, it needs to be stressed that Regenerative Medicine is a field of medicine.If a clinic chooses to perform just PRP therapy or commit to one form of stem cell therapy, it is not a Regenerative Medicine practice despite glossy marketing that suggests otherwise.One mode of therapy cannot possibly treat all ailments any more than one tool can fix all mechanical problems with one tool.It would behoove you as a patient to interview your provider and get a sense of their depth and breadth of understanding of this field of Medicine.

Make Neck and Spinal Pain Relief Happen

That's right...take a proactive role.Initial steps start before the injury even happens.Maintain a healthy weight by being mindful of a healthy diet.This may entail testing to ensure you're not mounting a low-grade inflammatory response to certain foods as well as checking to see if your calcium and vitamin levels are supportive of appropriate bone density.Exercise your neck and back.This will help with mobility, and musculoskeletal strength.Adopt practices in your daily activities that avoids injury rather than react to it once it happens.

If you do injure your neck or back, take an adequate amount of time off to recover fully.Don't cut corners as you risk significantly prolonging recovery - the opposite of the desired effect.

Finally, despite the pain being acute or chronic, learn to act early."Toughing it out" can be detrimental as over months and years, at the microscopic level, the injury can not only progress but lead to further damage that becomes unresponsive to conservative measures including to biological therapies.

Do your homework, research and meet with Regenerative Medicine specialists early.Share your goals and expectations with them and get a sense for what's realistic.Don't settle for cheap or lofty promises.Once the disease has advanced beyond the point of no return and surgery is the only option, repeat this process with more than one spine surgeon.Surgery is a major endeavor and being at your health optimum is paramount.Regenerative Medicine specialists can still offer vital help here - for example with a supportive post surgical injection to help shorten recovery time.

By Vasilly Eliopoulos and Khoshal Latifazai, Founders of Rocky Mountain Regenerative Medicine, is the only full-service integrative and regenerative medicine clinic of its kind in the nation specializing in Stem Cells for Spinal Disorders.

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Cell Transplantation for Spinal Cord Injury …

By daniellenierenberg

Spinal cord injury (SCI) is an intractable and worldwide difficult medical challenge with limited treatments. Neural stem/progenitor cell (NS/PC) transplantation derived from fetal tissues or embryonic stem cells (ESCs) has demonstrated therapeutic effects via replacement of lost neurons and severed axons and creation of permissive microenvironment to promote repair of spinal cord and axon regeneration but causes ethnical concerns and immunological rejections as well. Thus, the implementation of induced pluripotent stem cells (iPSCs), which can be generated from adult somatic cells and differentiated into NS/PCs, provides an effective alternation in the treatment of SCI. However, as researches further deepen, there is accumulating evidence that the use of iPSC-derived NS/PCs shows mounting concerns of safety, especially the tumorigenicity. This review discusses the tumorigenicity of iPSC-derived NS/PCs focusing on the two different routes of tumorigenicity (teratomas and true tumors) and underlying mechanisms behind them, as well as possible solutions to circumvent them.

Spinal cord injury is a devastating neurological condition, which results in the disruption of signals between the brain and body yielding severe physical, psychological, and social dysfunction [1, 2]. Patients who have suffered a SCI not only become increasingly dependent on others for daily life but are more likely to die prematurely and are at risk for social exclusion [1, 2]. What is worse is that, due to the complex pathophysiological processes, significant treatment for SCI has progressed slowly.

Originally, glucocorticoid drugs like methylprednisolone were regarded as the classic therapeutic treatment for SCI [3], as they had been found to stabilize the plasma membrane of damaged cells by inhibiting lipid peroxidation and hydrolysis [3]. However, their application gradually became controversial because they had serious side effects like mounting vulnerability to acute corticosteroid myopathy or serious infection [4, 5]. Other clinical approaches to SCI included early surgical interventions [6] and alternative pharmacological therapy (e.g., GM-1 [7] and thyrotropin-releasing hormone [8]). However, these methods either had their own side effects or demonstrated weakly therapeutic efficacy.

Recent progress in cell transplantation has opened up new opportunities to understand and treat SCI. Among the several types of candidate cells, NS/PC holds great therapeutic potential for SCI, as it can replace the lost neurons and glia as well as create a growth-promoting environment [9]. Nevertheless, the acquisition of NS/PCs can be a difficult task since they are usually located deep in the brain so their isolation is a highly invasive procedure. To bypass this problem, people have also used ESCs from which they can generate sufficient NS/PCs. Indeed, ESC-derived NS/PCs were initially reported to have optimistic effects on SCI [10, 11]. Unfortunately, the application of ESC-based strategy, accompanied by immune rejections and ethical concerns [12], was less likely to be transformed into clinical practice. Subsequently, the advent of iPSCs appears to signal the future of stem cell treatments for SCI. However, while the therapeutic effects of iPSCs on SCI have been discussed by many studies, the side effects are rarely mentioned and talked over exclusively, especially the tumorigenicity of iPSCs. In this paper, we briefly summarized the application of iPSCs, elucidated the tumorigenicity in detail, and described possible strategies to address it.

In 2006, Takahashi and Yamanaka showed that fibroblasts from mouse somatic cells could regain pluripotency after expressing four transcriptional factors [13], thus developing iPSCs. It stands to reason that iPSCs may have the greatest potential for regenerative medicine, because they have abilities to indefinitely self-renew and differentiate into most if not all cell types [13, 14]. Compared to ESCs, autologous iPSCs also circumvent the ethical issues associated with embryonic tissue harvesting and free patients of immunosuppression, which is critical since SCI patients are at high risk for infection [15].

Of late, an increasing number of research groups have applied iPSCs to SCI and achieved interesting results (Table 1). In 2010, Tsuji et al. managed to produce neurospheres from mouse iPSCs and showed that transplantation of these cells promoted functional improvement in mice with SCI [16]. As a proof of principle, they also used human iPSCs (hiPSCs) and demonstrated significant therapeutic effects like the better recovery of motor function, synapse formation between the grafts and hosts, and enhanced axonal regrowth [17]. Kobayashi et al. transplanted hiPSC-derived NS/PCs into a nonhuman primate following cervical SCI and revealed behavioral improvements consistent with rodent studies [18]. Lu et al. reported that not only can the derivatives of iPSCs extend axons over nearly the whole length of the rat CNS [19] but can also form extensive synaptic connections with the host. More recently, several studies have elucidated potential mechanisms underlying behavioral improvement from SCI following transplantation of iPSC derivatives [20, 21]. They speculated that iPSC derivatives exerted their effects on SCI by substitution of lost neural cells, promotion of axonal remyelination, and regrowth as well as tissue sparing through trophic support.

There are also some negative reports on iPSC approaches to SCI. Two reports revealed that despite the ability to differentiate into neural cells [19, 22], iPSC-derived NS/PCs did not show any substantial improvement in function. Besides, it takes a long time to generate and evaluate iPSCs [23], making it unrealistic for individualized iPSC-based therapy because the optimal time for stem cell transplantation is the subacute phase [24]. As a result, either iPSCs would have to be generated from donor tissue, missing out on the major factor that makes them attractive in the first place, or transplanted at more chronic phases of injury [25], which showed a poor result after transplantation into the chronic SCI model. More importantly, like ESCs, there are widely found issues with respect to safety of iPSCs, particularly the possible tumorigenicity [16, 21, 26].

Tumorigenicity of any stem cell transplants remains a major concern for clinical applications, and there is an urgent need for it to be addressed before translation of iPSC techniques into SCI treatment. From several reports [26, 27], tumorigenicity of iPSCs can be classified into two distinct types: teratoma and true tumors due to their different features and developmental processes, which we will discuss further below (Figure 1).

Teratoma is a relatively common potential risk in grafts of iPSCs especially when individual iPSC clones were preevaluated as unsafe [16, 17, 28]. While the mechanism is not fully understood, most reports share the idea that undifferentiated iPSCs lead to teratoma formation [26, 29]. Teratoma formation requires the ability to escape or silence the immune responses for the purpose of survival in the host. Tumor cells could take effective measures to avoid immune responses by alteration of MHC-I, mutations in Fas or Trail, and so forth [30]. These traits are well shared with undifferentiated iPSCs. Besides, like tumor cells, iPSCs possess a virtually unlimited proliferation potential, by which they are vulnerable to the formation of a cell mass. Therefore, we reasonably postulate that residual-undifferentiated cells contribute greatly to teratoma formation. Moreover, Miura et al. discovered that the presence or absence of c-Myc in iPSCs and drug selection for NANOG or Fbxo15 expression [28, 31], all of which are considered closely associated with tumorigenesis, showed no correlation with teratoma formation. Namely, the underlying mechanism of teratoma formation is different from that of tumor, as they do not correlate with these tumor makers.

It is still unclear why undifferentiated cells remain in iPSC grafts. However, iPSC derivatives of different origins do demonstrate different teratoma-forming propensity [16, 28]. For instance, iPSCs derived from tail-tip fibroblasts showed the highest propensity for teratoma formation while iPSCs from embryonic fibroblasts and gastric epithelial cells showed the lowest. Since iPSCs from different origins exhibited distinctive features, it is possible that epigenetic memory, the residual features of somatic tissues, plays a role in teratoma formation. And due to epigenetic memory, iPSCs from certain cell lines may be likely to redifferentiate back into their initial cell type [32, 33]. Therefore, we might as well hold the belief that if we created a certain type of microenvironment supporting certain iPSCs to differentiate into NS/PCs, those derived from any other cell lines except neural ones may not be able to well differentiate and have to maintain undifferentiated status under this unfavorable condition. Besides, the inefficient methods of purifying the contaminated undifferentiated cells also aggravate the situation.

Several studies have found that even if all undifferentiated cells are purged [26, 34], iPSC derivatives remain tumorigenic, as substantial tumors were present instead of teratomas. Such cases can be much worse because they are usually malignant and able to progress, invade, and metastasize. As such, understanding the mechanisms behind tumorigenesis is imperative.

The exact mechanism underlying iPSC tumorigenesis is still not clearly defined, but several factors are thought to contribute to it. Collectively, genomic and epigenomic instability correlates largely with tumorigenicity of iPSCs [35, 36]. Many factors can account for genomic instability. For instance, several oncogenes (like c-Myc and KLF4) or genes sometimes associated with tumorigenesis (like SOX2 and Oct-4) are used in the reprogramming process. Additionally, retroviral or lentiviral gene delivery systems are used in the reprogramming process and can be integrated into the genome-disrupting tumor suppressor genes and pathways. For example, the activation of transgenic Oct-4 and KLF4 has been found to induce tumor formation of NS/PCs via the Wnt/-catenin signaling pathway [34]. This pathway was found to be able to enhance stabilization of telomeres, a signature of tumorigenesis, by increasing TERT expression. Furthermore, the mature cells harvested for iPSC induction have themselves already undergone multiple rounds of division and might possess their own genetic instability before induction [37]. Also, the low-efficiency reprogramming process and incomplete suppression of transgenic factors result in some partially reprogramming cells, which take part in tumor forming.

On the other hand, epigenomic instability, especially DNA methylation, also plays a role in the formation of true tumors [26]. DNA methylation has been found to have strong association with tumorigenesis in cancer tissues [38]. For instance, if oncogenes possess hypomethylation in a cell sample, such cells may show a higher likelihood to form tumors and vice versa. Consistent with this idea, 253G1-hiPSCs as well as 253G1-iPSC-NS/PCs, which had DNA hypomethylation mainly in oncogenes and hypermethylation in tumor suppressor genes, were more likely to develop tumors when compared with 207B1-hiPSCs and NS/PCs, which did not. In addition, tumorigenicity can be enhanced as induced cells are passaged because the passage of iPSCs and iPSC-derived NS/PCs further alters the epigenetic profiles via DNA methylation.

As mentioned above, the formation of teratomas is largely attributed to undifferentiated cells. Based on this, some reports proposed various methods to address this problem including the following:(1)Increased number of passages to weaken epigenetic memory. Several studies observed the loss of epigenetic memory with increased passage number [33, 39]. iPSCs at late passage and ESCs became indistinguishable and acquired similar ability of differentiation. Therefore, the undifferentiated cell correspondingly reduced when iPSCs were capable enough of differentiation into other cells. While the underlying mechanism is not quite clear, two possible aspects may account for this phenomenon: (i) most of the iPSCs will gradually erase somatic marks as those cells passaged and/or (ii) those rare, fully reprogrammed cells become superior and then are picked up step by step [39].(2)Take advantage of epigenetic memory characteristics and use it to reprogram iPSCs away from a teratoma-inducing lineage. The propensity of iPSCs to differentiate bias into their starting cell lineage could be exploited to produce certain cell types. For example, to get more NS/PCs from iPSCs, we may ideally think of the utilization of neural cells. Some previous reports [40, 41] also confirmed that, in comparison with other cell lineages of origin, iPSCs from neural tissue are more likely and efficient to differentiate into NS/PCs. The more likely to differentiate into other cells, the less possibility of forming teratomas.(3)Improve the ability to purify iPSC-NS/PCs. It is essential to better gain bona fide iPSC-NS/PCs, as the potential for contamination with undifferentiated iPSCs presents a big chance of forming teratomas. Therefore, scientists have tried many ways to achieve the common goal including finding more specific cell surface makers and diminishing residual undifferentiated cells like inhibiting DNA topoisomerase II or stearoyl-coA desaturase [21, 42]. Accordingly, it does help but it still urgently needs to pan for desired unique makers or proper methods of depleting undifferentiated cells.(4)Transplant more mature cells instead of naive ones. It has been observed that teratomas formed from iPSC-derived NS/PCs were much smaller than those directly from iPSCs, indicating that predifferentiation of iPSCs can reduce certain aspects of tumorigenicity [43]. Consequently, grafting iPSCs directly in the treatment of SCI is not recommended.

Taken together, these ways to address undifferentiated cell contamination in iPSC-derived NS/PC transplants are, at least in part, currently effective, but it seems impossible for some of these methods to be translated into clinical application due to either the invasive operation or time-consumed culture to weaken epigenetic memory. And we had better transplanted relatively mature iPSC-derived NS/PCs instead of iPSC itself.

As for substantial tumors, we also have several effective steps to reduce the risk including the following:(1)Change the reprogramming methods into integration-free methods. Virally induced iPSCs with genomic integrations of transcriptional factors easily cause insertional mutagenesis and result in continual expression of residual factors in iPSCs [44]. Thus, instead of using integrative vectors like retrovirus or lentivirus, we need to pursue integration-free methods, not perturbing the genome. Episomal vector and Sender virus vector were once thought to be ideal nonintegrating methods, as the former works as extrachromosomal DNA in the nucleus while the latter is a method of transgene-free induction. But as the potential spontaneous integration by episomal vector and the involvement viral particles, both are limited to clinical applications. Subsequently, Woltjen et al. discovered that piggyBac transposons could be integrated into genomes of the host so the reprogramming factors that they carried were able to express continuously and stably [45]. Furthermore, the piggyBac transposons could be cut out of the genomes completely [45]. Afterwards, the advent of DNA-free and viral-free methods like recombinant proteins, messager RNA, and mature microRNA made iPSCs stride towards clinical use despite being technically challenging or inefficient. Of note, iPSCs of the first clinical trial were generated by the nonintegrative method of reprogramming with recombinant proteins [46].(2)Avoid using transgenic factors of oncogenesis. The Yamanaka factors are competent enough to induce tumorigenesis playing important roles in the development and maintenance of cancer. It appears quite necessary to reduce reprogramming factors in order to decrease the possibility of tumor formation and hasten the clinical use. Nakagawa et al. initiated a series of experiments to test whether fewer factors are capable enough of inducing the stem cell. It was found that exogenous c-Myc was not necessarily needed to generate iPSCs [31]. They then found that exogenous Oct-4 together with KLF4 or SOX2 could produce iPSCs from NSC. Furthermore, they discovered that transcriptional factor Oct-4 alone is sufficient to acquire iPSCs [41]. Although the low-reprogramming efficiency of them limits their applications, their attempt provides us with new ideas.(3)Reduce undesirable DNA methylation. Decreasing DNA methylation of tumor suppressor genes and increasing that of oncogenes can certainly reduce the rate of tumor formation from iPSCs. The application of knocking down the maintenance methyltransferase DNMT1 or the demethylating agent like 5-AZA can reduce residual methylation of resulting cells and convert them to authentic pluripotent cells [33]. Besides, Mikkelsen et al. found that demethylation appears passage dependent [47]. Some reports showed that DNA methylation could be gradually erased as the cells were passaged [33, 39]. Iida et al. [26], however, found that DNA methylation patterns became more unstable with cells passaged. Maybe, this can be accounted for the fact that the cell clones that they used were different indicating that the ability of passaging to gradually diminish methylation cannot be applicable to all clones.(4)Establish reliable ways to distinguish the safe and unsafe cell clones. By virtue of the teratoma-forming activity of the iPSC derivatives after their transplantation [28], we are capable of differentiating the safe iPSC clones from all cultured cell clones. Preevaluated safe clones can show significant therapeutic effects without tumor formation [1618], while preevaluated unsafe clones demonstrate high rates of tumor formation. Iida discovered that methylation states of CAT and PSMD5 genes can be applied to discriminate between safe and unsafe hiPSC-NS/PCs [26].

In brief, across the entire process of iPSC generation and NS/PC differentiation, there are steps that can be taken to reduce nonteratoma tumor formation. These strategies mentioned above just provide some possible way to circumvent the tumorigenicity, but I am afraid that there is still a long way from clinical applications.

Despite numerous therapeutic discoveries in the laboratory, to our knowledge, faithfully effective treatment for spinal cord injury remains unavailable. iPSC transplantation for SCI is currently an unrealistic strategy, but we have already recognized the huge potential of iPSCs for SCI because of their ability to self-renew and differentiate into various types of neural cells. In addition, iPSCs also avoid the ethical issues associated with some transplant sources and importantly can be performed in an autologous manner removing the need for immune suppression.

However, although the Takahashi group claimed that they were warranted to restart their clinical trials on iPSCs, safety concerns, especially tumorigenicity, still seriously limit considerations for clinical application, at least on SCI [48]. They once carried out the first clinical application of iPSCs in 2014, but were required to halt for some reasons. In this review, we focused on the two different routes of tumorigenicity and underlying mechanisms behind them. We also put forward some potential solutions to tumorigenesis. But in the current state, not enough is understood about underlying causes of tumor genesis from iPSC derivatives to completely elucidate the issue. More explorations and attempts need to be done in the future.

The authors declare that they have no competing interests.

Junhao Deng wrote the initial manuscript. Yiling Zhang, Yong Xie, and Licheng Zhang participated in drafting the manuscript. Peifu Tang revised the manuscript. All authors read and approved the final manuscript.

The authors thank Xie Wu and their laboratory members for their dedicated work. They are supported by the projects of the international cooperation and exchanges of the National Natural Science Foundation of China (81520108017).

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Knowing the Global Cell Therapy Market; MRFR Reveals Insights for 2017 2023 – The Daily Chronicle

By daniellenierenberg

Cell Therapy Market Highlights

Acknowledging the increasing traction that the market is garnering currently, Market Research Future (MRFR) in its recently published analysis asserts that the global cell therapy market is expected to witness significant accruals, growing at a 10.6% CAGR during the forecast period (2017-2023).

Cell therapy has evolved as a recent phase of the biotechnological revolution in the medical sector. The key aim of cell therapy is to target various diseases at the cellular level by restoring a specific cell population as carriers of therapeutic cargo. Besides, cell therapy is used in combination with gene therapy for the treatment of several diseases.

Potential applications of this therapy include treatment of urinary problems, cancers, autoimmune disease, neurological disorders, and infectious disease. In the future, cell therapy will also be used for rebuilding damaged cartilage in joints, repairing spinal cord injuries, and improving the immune system.

Globalcell therapy marketis proliferating rapidly. Factors predominantly driving the growth of the market include the rising prevalence of chronic diseases and disorders, increasing geriatric population, increasing government assistance, and replacement of animal testing models. Besides, technological advancements transpired in the field of biotechnology are escalating the market on the global platform.

Additional factors pushing up the growth of the market include the growing number of neurological disorders and the improvement in the regulatory framework. Other dominant driving forces behind the growth of the global cell therapy market are the regulation of tissue engineering and the exciting possibilities that this therapy is offering in the field of therapeutics.

Conversely, factors such as the challenges that occurred during research and development activities impede the growth of the market. Also, the high cost associated with the development and reconstruction of cells is hampering the market growth especially in the developing and under-developed countries.

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Global Cell Therapy Market Segmentation

For enhanced understanding, the market has been segmented into six key dynamics:

By Type:Autologous and Allogeneic

By Technology:Somatic Cell Technology, Cell Immortalization Technology, Viral Vector Technology, Genome Editing Technology, Cell Plasticity Technology, and Three-Dimensional Technology among others.

By Source:Induced Pluripotent Stem Cells (iPSCs), Bone Marrow, Umbilical Cord Blood-Derived Cells, Adipose Tissue, and Neural Stem Cell among others.

By Application:Musculoskeletal, Cardiovascular, Gastrointestinal, Neurological, Oncology, Dermatology, Wounds & Injuries, and Ocular among others.

By End-users:Hospital & Clinics, Regenerative Medicine Centers, Diagnostic Centers, and Research Institutes among others.

By Regions:North America, Asia Pacific, Europe, and the Rest-of-the-World.

Major Players

Key players leading the global cell therapy market include GlaxoSmithKline plc, Novartis AG, MEDIPOST, PHARMICELL, Osiris,NuVasive, Inc.,Anterogen.Co., Ltd., JCR Pharmaceuticals Co., Ltd, CELLECTIS,Cynata,BioNTechIMFS, Cognate, EUFETS GmbH,Pluristem, Genzyme Corporation, Grupo Praxis, and Advanced Tissue among others.

Global Cell Therapy Market Regional Analysis

The North American region, heading with the successful advancements in therapies dominates the global cell therapy market with a significant share. The market is further expected to grow phenomenally, continuing its dominance from 2017 to 2023. Moreover, the growing number of patients suffering from chronic diseases such as cancer and cardiovascular disorders and well-defined per capita healthcare expenditure are acting as major tailwinds, driving the growth of the regional market.

The US, backed by its huge technological advancements, accounts for the major contributor to the cell therapy market in North America. Furthermore, an increasing number of care facilities offering cell therapies alongside the advanced devices contribute to the growth of the regional market. Also, factors such as the presence of the well-established players, availability of funding for the development of new therapeutics, and treatment positively impact the growth of the market.

The cell therapy market in the European region accounts for the second largest market, globally, expanding at a phenomenal CAGR. The resurging economy in Europe is undoubtedly playing a key role in fostering the growth of the regional market. Additionally, factors such as the availability of technologically advanced devices and the proliferation of quality healthcare along with the increasing healthcare cost contribute to the market growth in the region. Besides, the accessibility to the advanced technology and increasing government support for the R&D activities, propel the market growth in the region.

The Asia Pacific cell therapy market is rapidly emerging as a profitable market, globally. Factors such as the support provided by the government and private entities for research & development will drive the market in the region. Moreover, factors such as the vast advancements in biotechnology and cell reconstructive methods are fostering the growth in the regional market. Furthermore, the rapidly growing healthcare sector led by improving economic conditions positively impacts the regional market. Also, developing healthcare technology and the large unmet needs will foster the growth of the market in the region.

GlobalCell TherapyMarket Competitive Analysis

Highly competitive, the cell therapy market appears to be widely expanded and fragmented characterized by several small and large-scale players. To gain a competitive edge and to sustain their position in the market, these players incorporate various strategic initiatives such as partnership, acquisition, collaboration, expansion, and product launch.

The structure of the market is changing due to the acquisition of local players by multinational companies. Because of the increasing competition in the market, multinational companies are using the strategy of acquisition, which increases the profit of the company while significantly reducing the competition.

Industry, Innovation & Related News

March 12, 2019 -Cell Medica Ltd. (the UK), a leading global company engaging in the development, manufacture, and commercialization of cellular immunotherapy products for the treatment of cancer and viral infections announced the receiving of a grant of USD 8.7 MN from the Cancer Prevention and Research Institute of Texas (CPRIT the US) to accelerate off-the-shelf CAR-NKT cell therapy.

In addition to being available off-the-shelf, the new cell-based therapy CMD-502 uses donor-derived natural killer T-cells to fight cancer and is expected to have a better safety profile than current chimeric antigen receptor (CAR) T-cell therapies. The therapy is being developed and refined in collaboration with the Baylor College of Medicine (BCM Texas, the US).

Browse Complete Report with TOC athttps://www.marketresearchfuture.com/reports/cell-therapy-market-5066

About Market Research Future:

AtMarket Research Future (MRFR), we enable our customers to unravel the complexity of various industries through our Cooked Research Report (CRR), Half-Cooked Research Reports (HCRR), Raw Research Reports (3R), Continuous-Feed Research (CFR), and Market Research & Consulting Services.

MRFR team have supreme objective to provide the optimum quality market research and intelligence services to our clients. Our market research studies by Components, Application, Logistics and market players for global, regional, and country level market segments, enable our clients to see more, know more, and do more, which help to answer all their most important questions.

In order to stay updated with technology and work process of the industry, MRFR often plans & conducts meet with the industry experts and industrial visits for its research analyst members.

Contact:

Akash Anand

Market Research Future

+1 646 845 9312

Email:[emailprotected]

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Knowing the Global Cell Therapy Market; MRFR Reveals Insights for 2017 2023 - The Daily Chronicle

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Liver Disease Stem Cell Therapy | NSI Stem Cell

By daniellenierenberg

Stem Cell Therapy for Liver Cirrhosis

Chronic Liver Disease is a major concern for the entire country as it ranks as the fifth largest killer in the world. When the liver sustains serious damage, it loses the ability to repair itself and begins to function less and less effectively until it reaches the point that it no longer works, which is a life-threatening condition. An effective liver failure therapy was pursued for decades before the discovery of stem cells offered the possibility of effective liver stem cell therapy. Until the advent of Advanced Liver Stem Cell Therapy, the only therapy option for liver disease was a full organ transplant. Our bone marrow-derived stem cell therapies for liver conditions are an innovative therapy practiced in the United States that is safe and effective.*

We want to see patients with liver disease have a better quality of life and even be able to reverse the damage done. Liver stem cell therapy is one of our latest and most exciting therapies, joining those available at our clinic like stem cell therapy for Neurological or Spinal Cord Conditions.

The liver is a multi-functional organ that plays a role in digestion, blood sugar control, blood clotting factors for healing, making amino acids, increasing red blood cell growth, fat and cholesterol transport, and the removal of waste, especially toxic exposures and the metabolization of medications into their active ingredients. Much research has been done on this vital organ, and we now understand how Liver Stem Cell Therapy can positively impact liver health and function.

A number of things can contribute to Liver Disease. Here are some of the most commonly seen diagnoses in our offices:

Cirrhosis is the medical term that is used to describe liver disease that permanently scars the liver, which results in reduced function, pain, waste build up, and ultimately death of the liver. Its potentially lethal consequences make effective cirrhosis of he liver therapy a matter of the utmost importance.

When this condition is present, normal liver cells are replaced by scar tissue that cannot maintain healthy liver function. Acute liver failure may be life-threatening. Stem Cell Therapy for Liver Cirrhosis is a form of liver cirrhosis therapy that addresses damage as well as helps to generate fresh, healthy tissue.

Not too long ago, a diagnosis of liver failure was a death sentence, as the condition was deemed irreversible. However, new advances in stem cell regeneration have made Liver Stem Cell Therapy, including Stem Cell Therapy for Liver Cirrhosis, a reality.

More than three-quarters of the liver is made up of hepatocyte liver cells, which are special in that their average lifespan is only 150 days. What this means is that the liver is constantly renewing and growing new cells to replace weak and dying cells. It is the only organ in the body that can easily replace damaged cells. But when too many cells are damaged or die off too soon, the liver cannot keep up and it begins to fail into Liver Disease. Helping the organ to grow new cells is one of the functions of NSIs Liver Stem Cell Therapy.

The liver is a regenerative organ. But it is limited in this ability and can only maintain the regenerative pace when there are enough energy, healthy cells, blood, oxygen, and proper nutrients available. Liver Disease can quickly get out of control and can progress to Cirrhosis and Liver Failure very rapidly. Liver Stem Cell Therapy is designed to help reverse this damage and speed the process of cell regeneration.

Although the liver can heal itself, there is a point of no return, and there are not enough signs to indicate there is a problem until it is too late. Prior to Liver Stem Cell Therapy, once the line was crossed between Chronic Liver Disease and the final stage of liver failure, there were few options. Transplantation was the only effective therapy option for liver failure.

But it, too, is not without its share of risks and drawbacks. Rejection of the donor organ, infections, and surgery complications are at the top of the list. It is estimated that for every donor organ, there are 30 patients on a waiting list, and many people die from end-stage Liver Disease waiting for a donor organ.

This is why there has been such a fervent interest in liver failure therapy using stem cells here at NSI Stem Cell Centers.

Going back to as far as the year 2000, researchers have been conducting studies that showed that hepatocyte cells could grow on non-liver cell sources. This means there do not have to be associated liver cells to stimulate the liver cells to continue multiplying. This phenomenon is called transdifferentiation and is integral to Liver Stem Cell Therapy. Our bone marrow-derived stem cell therapies for liver conditions are an innovative therapy practiced in the United States that is safe and effective.*

Today, stem cells that are taken from the patients own fatty deposits are the only stem cells that have successfully been used in addressing liver disease. The major advantage that comes from such stem cells is that they do indeed come from the patient, so rejection is not an issue and there is a much higher success rate and a much-improved growth of new liver cells seen for the patient.

The stem cells are harvested and then transplanted into the damaged liver, where they transdifferentiate into hepatocyte cells. The stem cells also become cells that help with blood and oxygen delivery and waste removal, so the liver can regenerate faster.

To learn more about how Liver Stem Cell Therapy can help you fight your liver disease, contact us today at NSI Stem Cell and set up an appointment at one of our Florida locations. Our phone number is (877) 278-3623, or use our Contact Page. Be sure to ask for our FREE brochure that explains all of our Stem Cell Therapies. We look forward to hearing from you.

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Liver Disease Stem Cell Therapy | NSI Stem Cell

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Stem Cell Grafts Show Functionality in Spinal Cord Injuries

By daniellenierenberg

In mouse studies, the specialized grafts integrated with host networks and behaved much like neurons in a healthy, undamaged spinal cord.

Using stem cells to restore lost functions due to spinal cord injury (SCI) has long been an ambition of scientists and doctors. Nearly 18,000 people in the United States suffer SCIs each year, with another 294,000 persons living with an SCI, usually involving some degree of permanent paralysis or diminished physical function, such as bladder control or difficulty breathing.

In a new study, published August 5, 2020 in Cell Stem Cell , researchers at University of California San Diego School of Medicine report successfully implanting highly specialized grafts of neural stem cells directly into spinal cord injuries in mice, then documenting how the grafts grew and filled the injury sites, integrating with and mimicking the animals existing neuronal network.

Until this study, said the studys first author Steven Ceto, a postdoctoral fellow in the lab of Mark H. Tuszynski, MD, PhD, professor of neurosciences and director of the Translational Neuroscience Institute at UC San Diego School of Medicine, neural stem cell grafts being developed in the lab were sort of a black box.

Although previous research, including published workby Tuszynski and colleagues, had shown improved functioning in SCI animal models after neural stem cell grafts, scientists did not know exactly what was happening.

We knew that damaged host axons grew extensively into (injury sites), and that graft neurons in turn extended large numbers of axons into the spinal cord, but we had no idea what kind of activity was actually occurring inside the graft itself, said Ceto. We didnt know if host and graft axons were actually making functional connections, or if they just looked like they could be.

Ceto, Tuszynski and colleagues took advantage of recent technological advances that allow researchers to both stimulate and record the activity of genetically and anatomically defined neuron populations with light rather than electricity. This ensured they knew exactly which host and graft neurons were in play, without having to worry about electric currents spreading through tissue and giving potentially misleading results.

They discovered that even in the absence of a specific stimulus, graft neurons fired spontaneously in distinct clusters of neurons with highly correlated activity, much like in the neural networks of the normal spinal cord. When researchers stimulated regenerating axons coming from the animals brain, they found that some of the same spontaneously active clusters of graft neurons responded robustly, indicating that these networks receive functional synaptic connections from inputs that typically drive movement. Sensory stimuli, such as a light touch and pinch, also activated graft neurons.

We showed that we could turn on spinal cord neurons below the injury site by stimulating graft axons extending into these areas, said Ceto. Putting all these results together, it turns out that neural stem cell grafts have a remarkable ability to self-assemble into spinal cord-like neural networks that functionally integrate with the host nervous system. After years of speculation and inference, we showed directly that each of the building blocks of a neuronal relay across spinal cord injury are in fact functional.

Tuszynski said his team is now working on several avenues to enhance the functional connectivity of stem cell grafts, such as organizing the topology of grafts to mimic that of the normal spinal cord with scaffolds and using electrical stimulation to strengthen the synapses between host and graft neurons.

While the perfect combination of stem cells, stimulation, rehabilitation and other interventions may be years off, patients are living with spinal cord injury right now, Tuszynski said. Therefore, we are currently working with regulatory authorities to move our stem cell graft approach into clinical trials as soon as possible. If everything goes well, we could have a therapy within the decade.

Co-authors of the study are Kohel J. Sekiguchi and Axel Nimmerjahn, Salk Institute for Biological Studies and Yoshio Takashima, UC San Diego and Veterans Administration Medical Center, San Diego.

Funding for this research came, in part, from Wings for Life, the University of California Frontiers of Innovation Scholars Program, the Veterans Administration (Gordon Mansfield Spinal Cord Injury Collaborative Consortium, RR&D B7332R), the National Institutes of Health (grants NS104442 and NS108034), The Craig H. Neilsen Foundation, the Kakajima Foundation, the Bernard and Anne Spitzer Charitable Trust and the Dr. Miriam and Sheldon G. Adelson Medical Research Foundation.

Source: Scott LaFee, UC San Diego School of Medicine

Posted on August 5th, 2020 in Uncategorized.

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Stem Cell Grafts Show Functionality in Spinal Cord Injuries

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Repairing damage caused by spinal cord injury with stem cells

By daniellenierenberg

Although spinal cord injuries (SCI) are not as prevalent as other debilitating conditions, they can be particularly devastating. Patients often lose motor control and sensibility and require assistance with everyday tasks. Most people are familiar with the case of Christopher Reeve, an American actor who played Superman in the 70s and 80s. He suffered a cervical spinal cord injury and was left paralyzed from the neck down. Reeve became an advocate for research into a potential cure using stem cells.

The World Health Organization estimates that every year up to 500,000 people suffer this type of injury worldwide. In Canada, approximately 85,000 people are currently living with some type of SCI.

The possibility of repairing damage sustained by the spinal cord is one of the most exciting potential applications of regenerative medicine. There have been promising advancements in this field and it is just a matter of time before they give way to actual treatments. Access to these treatments is just one of the many advantages of cell banking.

Inside the spinal column, which runs from the base of the skull to the coccyx, lies a fragile structure made up of nervous tissue. This is the spinal cord. Its job is to carry nerve signals from the brain to the rest of the body.

The spinal cord is very delicate and while it is protected by the vertebrae, it can easily be damaged either by trauma or disease. Injuries are graded according to their severity on a scale designed by the American Spinal Injury Association (ASIA) that goes from A to E (A being a complete injury, where all motor and sensory function is lost. E represents normal function). The severity of the injury is inversely correlated with the probability of recovery. According to the American Association of Neurological Surgeons, nearly half of all spinal cord injuries are complete.

In addition to the physical damage, spinal cord injuries are incredibly challenging in psychological terms. The more severe the injury, the more likely it is that the individual will lose the ability to care for himself. As reported in Mayo Clinic Proceedings, adults with spinal cord injury are at a higher risk of developing mental health disorders. Additionally, the rate of suicide increases three-fold among patients with this type of injury compared to the general population.

In a study published in Topics in Spinal Cord Injury Rehabilitation, researchers from the University of Alabama analyzed data from patients that sustained spinal cord injuries from 2005 to 2011. They found that automobile crashes (31.5% of cases) and falls (25.3%) account for more than half of all incidents. Other common causes are gunshot wounds, motorcycle crashes, and diving accidents. Although not frequent, diseases can cause spinal cord injury as well, specifically cancer, and osteoporosis.

Considering all causes, men account for 8 out of every 10 cases of spinal cord injury. Additionally, according to the Mayo Clinic, people are more likely to suffer traumatic cord injuries between the ages of 16 and 30. Avoiding risky behavior is the most effective strategy for preventing spinal cord injury.

In addition to the ASIA scale, which ranks injury by the severity of the damage, spinal cord injuries can be classified depending on the area affected. There are four types of spinal cord injury: cervical, thoracic, lumbar, and sacral.

The uppermost portion of the spine (vertebrae C1 to C7) is called the cervical section. Traumatic cord injuries in this area can lead to quadriplegia or full paralysis. This is the sort of injury that actor Christopher Reeve sustained. He shattered his C-1 and C-2 vertebrae in a horseback riding accident. Baseball player Roy Campanella damaged his C-5 and C-6 vertebrae in an automobile accident.

The thoracic spine is comprised of 12 vertebrae (T-1 to T-12) and it is located below the cervical section. An injury to this area could result in loss of use of the chest, upper back, and abdominals.

The lumbar section of the spine is located in the lower back. It comprises five vertebrae (L1 to L5). An injury to this area can leave an individual paraplegic, unable to move or feel anything below the point of injury. Deng Pufang, son of Chinas former leader Deng Xiaoping, suffered a lumbar spinal cord injury and became paralyzed.

The sacral section is located between the lumbar section and the coccyx. Injury to this area may cause loss of function in the hips and legs. Bladder function may be compromised as well. Injuries to this section of the spine are less common than cervical, thoracic, or lumbar injuries.

A discovery made by researchers John B. Gurdon and Shinya Yamanaka, for which they won the 2012 Nobel Prize in Medicine, may hold the key to repairing spinal cord injury. They found a way to induce adult cells, like those located in your hair follicles, to become pluripotent. Once this happens, these cells, called induced pluripotent stem cells (iPSCs), can become any cell type in the body.

A team of researchers from Keio University in Japan injected mice that had suffered spinal cord injury with neural cells derived from human iPSCs. These cells were able to successfully migrate and differentiate into their appropriate neural lineages, and they performed synapses. This means that they became exactly the type of cell needed in the place of injury and they successfully communicated with each other.

According to the scientists, compared to the control group, the mice injected with iPSCs had a significantly better functional recovery. The results of this trial, published in Proceedings of the National Academy of Sciences of the United States of America, are a step forward in the path towards eventually promoting complete functional recovery of spinal cord injury in humans.

Once this method is perfected and made available to the public, doctors will need a cell sample that they can turn into neural cells to treat people who suffer from spinal cord injury. It is important to note that the sooner that sample is taken and preserved, the higher its therapeutic potential will be, not only to treat spinal cord injury but many other conditions like Parkinsons, Alzheimers and macular degeneration.This means that the sooner you take action and have your live cells cryopreserved, the better prepared you will be to take advantage of the revolution of regenerative medicine that is coming. To learn more about the ways you can have your cells banked at Acorn, click here.

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Repairing damage caused by spinal cord injury with stem cells

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Implanted Neural Stem Cell Grafts Show Functionality in …

By daniellenierenberg

Colorized scanning electron micrograph of a cultured human neuron. Photo credit: Thomas Deerinck, UC San Diego National Center for Microscopy and Imaging

Using stem cells to restore lost functions due to spinal cord injury (SCI) has long been an ambition of scientists and doctors. Nearly 18,000 people in the United States suffer SCIs each year, with another 294,000 persons living with an SCI, usually involving some degree of permanent paralysis or diminished physical function, such as bladder control or difficulty breathing.

In a new study, published August 5, 2020 in Cell Stem Cell, researchers at University of California San Diego School of Medicine report successfully implanting highly specialized grafts of neural stem cells directly into spinal cord injuries in mice, then documenting how the grafts grew and filled the injury sites, integrating with and mimicking the animals existing neuronal network.

Until this study, said the studys first author Steven Ceto, a postdoctoral fellow in the lab of Mark H. Tuszynski, MD, PhD, professor of neurosciences and director of the Translational Neuroscience Institute at UC San Diego School of Medicine, neural stem cell grafts being developed in the lab were sort of a black box.

Although previous research, including published work by Tuszynski and colleagues, had shown improved functioning in SCI animal models after neural stem cell grafts, scientists did not know exactly what was happening.

We knew that damaged host axons grew extensively into (injury sites), and that graft neurons in turn extended large numbers of axons into the spinal cord, but we had no idea what kind of activity was actually occurring inside the graft itself, said Ceto. We didnt know if host and graft axons were actually making functional connections, or if they just looked like they could be.

Ceto, Tuszynski and colleagues took advantage of recent technological advances that allow researchers to both stimulate and record the activity of genetically and anatomically defined neuron populations with light rather than electricity. This ensured they knew exactly which host and graft neurons were in play, without having to worry about electric currents spreading through tissue and giving potentially misleading results.

They discovered that even in the absence of a specific stimulus, graft neurons fired spontaneously in distinct clusters of neurons with highly correlated activity, much like in the neural networks of the normal spinal cord. When researchers stimulated regenerating axons coming from the animals brain, they found that some of the same spontaneously active clusters of graft neurons responded robustly, indicating that these networks receive functional synaptic connections from inputs that typically drive movement. Sensory stimuli, such as a light touch and pinch, also activated graft neurons.

We showed that we could turn on spinal cord neurons below the injury site by stimulating graft axons extending into these areas, said Ceto. Putting all these results together, it turns out that neural stem cell grafts have a remarkable ability to self-assemble into spinal cord-like neural networks that functionally integrate with the host nervous system. After years of speculation and inference, we showed directly that each of the building blocks of a neuronal relay across spinal cord injury are in fact functional.

Tuszynski said his team is now working on several avenues to enhance the functional connectivity of stem cell grafts, such as organizing the topology of grafts to mimic that of the normal spinal cord with scaffolds and using electrical stimulation to strengthen the synapses between host and graft neurons.

While the perfect combination of stem cells, stimulation, rehabilitation and other interventions may be years off, patients are living with spinal cord injury right now, Tuszynski said. Therefore, we are currently working with regulatory authorities to move our stem cell graft approach into clinical trials as soon as possible. If everything goes well, we could have a therapy within the decade.

Co-authors of the study are Kohel J. Sekiguchi and Axel Nimmerjahn, Salk Institute for Biological Studies and Yoshio Takashima, UC San Diego and Veterans Administration Medical Center, San Diego.

Funding for this research came, in part, from Wings for Life, the University of California Frontiers of Innovation Scholars Program, the Veterans Administration (Gordon Mansfield Spinal Cord Injury Collaborative Consortium, RR&D B7332R), the National Institutes of Health (grants NS104442 and NS108034), The Craig H. Neilsen Foundation, the Kakajima Foundation, the Bernard and Anne Spitzer Charitable Trust and the Dr. Miriam and Sheldon G. Adelson Medical Research Foundation.

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New Study Presents Cell-based Therapy for MN Diseases or Spinal Cord Disorders – Mirage News

By daniellenierenberg

The spinal cord is a bundle of nerves inside the spine that gives your body structure and support. Spinal cord injuries (SCIs) tend to be devastating and most are permanent. Recent research has shown that motor neuron obtained from skin cells could serve as potential treatments for spinal cord injuries, and thus has received considerable research attention. With this, a new door has been opened for treating not only spinal cord injuries, caused by workplace accidents and car crashes, but also Lou Gehrigs disease, known as amyotrophic lateral sclerosis or ALS.

A research team, led by Professor Jeong Beom Kim and his research team in the School of Life Sciences at UNIST has demonstrated that human fibroblasts can be converted into induced motor neurons (iMNs) by sequentially inducing two transcription factors, POU5F1(OCT4) and LHX3. The research team further investigated the therapeutic effects of iMNs for treating traumatic spinal cord injury using rodent spinal cord injury model. Their findings indicate that the sequential induction of two transcription factors is essential for generating self-renewing iMNICs more efficiently. This method not only ensures large-scale production of pure iMNs, but also facilitates the feasibility of iMNs for SCI treatment.

The spinal cord is responsible for transmitting signals from the brain to the rest of the body, and vice versa. Along with motor and sensory deficits, damage to the spinal cord can cause long-term complications, including limited mobility. Although there are many treatment options available for people with SCI, most of them have adverse side effects that impact therapy. And this is why stem cell (SC) therapies to restore functions of damaged tissues are attracting attention, recently. Among those cells constituting the spinal cord, motor neurons that involved in the regulation of muscle function have emerged as a promising candidate for the stem cell-based therapy for SCIs. Despite these encouraging advances, ethical issue of embryonic stem cells (ESCs) and tumorigenic potential of induced pluripotent stem cells (iPSCs) have impeded their translations into clinical trials.

Figure 1. The experimental scheme for the generation of induced motor neurons (iMNs) from human fibroblasts via sequential transduction of two transcription factors.

To overcome these limitations, Professor Kim and his research team established an advanced direct conversion strategy to generate iMNs from human fibroblasts in large-scale with high purity, thereby providing a cell source for the treatment of SCI. These iMNs possessed spinal cord motor neuronal identity and exhibit hallmarks of spinal MNs, such as neuromuscular junction formation capacity and electrophysiological properties in vitro. Importantly, their findings also show that transplantation of iMNs improved locomotor function in rodent SCI model without tumor formation. According to the research team, This proof-of-concept study shows that our functional iMNs can be employed to cell-based therapy as an autologous cell source. Through this, they resolved the problem of immune rejection, and thus reduce the risk of cancer.

In the study, we succeeded in generating iMNs from human fibroblasts by overexpressing POU5F1(OCT4) and LHX3, says Hyunah Lee (Combined MS/Ph.D program of Life Sciences, UNIST), the first author of the study.

Figure 2. Therapeutic effects of iMNs in rat spinal cord injury model in vivo. (A) The position of hindlimbs in control rat and iMN-transplanted rat after 8 weeks of transplantation. (B) C staining analysis of spinal cords after 8 weeks of transplantation (I; Control, J; iMN-transplanted).

The developed motor nerve cell manufacturing method has the advantage of being capable of mass production. A sufficient amount of cells is required for patient clinical treatment, but the existing direct differentiation technique has limited the number of cells that can be obtained. On the other hand, the method developed by the research team is capable of mass production because it undergoes an intermediate cell stage capable of self-renewal. After injecting the produced cells into the spinal cord injury mice, it was confirmed that the lost motor function is restored and the nerves are regenerated in the damaged spinal cord tissue.

Although further investigation on mechanism responsible for cell fate conversion may be needed, our strategy is a safer and simpler methodology that may provide new insights to develop personalized stem cell therapy and drug screening for MN diseases or spinal cord disorders, says Professor Kim. If combined with SuPine Patch, an adhesive hydrogel patches with the purpose of regenerating the damaged spinal cords, its therapeutic effects will be maximized. He adds, As the incidence of spinal cord injury is high due to industrial accidents, synergistic effects with public hospitals specializing in industrial accidents scheduled to be built in Ulsan should be expected.

This study has been jointly carried out with Professor Kims startup company, SuPine Therapeutics Inc. with the support of the Ministry of SMEs and Startups (MSS). The findings of this research have been published in the 2020 June issue of the online edition of eLife, a renowned academic journal of the European Molecular Biology Organizationl (EMBO).

Journal Reference

Hyunah Lee, Hye Yeong Lee, Byeong Eun Lee, et al., Sequentially induced motor neurons from human fibroblasts facilitate locomotor recovery in a rodent spinal cord injury model, eLife, (2020).

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Re-Stem-Funded Study Targeting Mitochondrial Dysfunction in Aging and Age-Related Diseases Published in Science Advances Journal – Press Release -…

By daniellenierenberg

Aug. 9, 2020 / PRZen / SUZHOU, China -- Re-Stem Biotech (Re-Stem or the Company), a biotechnology firm engaged in the research and development of cell therapies targeting osteoarthritis, spinal cord injury and various cancers recently funded in part a study titled "Solid-phase inclusion as a mechanism for regulating unfolded proteins in the mitochondrial matrix". Researchers at The Johns Hopkins University School of Medicine, led by Rong Li, Ph.D., published their findings in the journal "Science Advances" (view full article here: https://advances.sciencemag.org/content/6/32/eabc7288) The study may provide mechanistic insights for mitochondrial dysfunction observed in aging and age-related diseases.

About Mitochondrial DysfunctionMitochondrial dysfunction is a hallmark of age-related diseases, such as cardiovascular diseases and neurodegenerative diseases. During aging, damaged/unfolded proteins in mitochondria that are failed to be degraded gradually accumulate. In addition, recent evidence suggests that non-mitochondrial proteins constituting pathological aggregates in neurodegenerative diseases also accumulate in mitochondria and cause mitochondrial dysfunction. However, it remains unclear how excessive damaged proteins are managed within mitochondria when known quality control mechanisms become inadequate, and how they contribute to mitochondrial dysfunction during the aging process.

About the StudyThe researchers discovered that excessive unfolded proteins in the mitochondrial matrix are consolidated into novel structures, which they named Deposits of Unfolded Mitochondrial Proteins (DUMP). DUMP formation is an age-dependent process, while accelerated DUMP formation causes mitochondrial dysfunction and premature aging. They found that DUMP formation was not random, but specific in mitochondria near endoplasmic reticulum (ER), another organelle in cells. The contact sites between mitochondria and ER regulate DUMP formation via transferring lipids between two organelles. Via a series of genetic and live-cell imaging studies, researchers identified key enzymes of mitochondrial lipid metabolism that control DUMP formation. Manipulation of these enzymes modulates DUMP formation, therefore, potentially they could be targets for anti-aging or treating age-related diseases.

About Re-Stem BiotechRe-Stem Biotech (Re-Stem) is a biotechnology firm engaged in the research and development of cell-based therapies and products. Backed by state of the art GMP facilities and an international team of world-leading scientists, doctors and management team, Re-Stem currently has a robust technology platform including four profitable therapies on the market and eight other therapies and products in the pipeline. Incorporated and headquartered in 2012 in Suzhou, China, Re-Stem is focused on the large and aging population of China. It also operates clinics and research and development laboratories in Shenzhen, Beijing, Kunming and Ganzhou. For more information visit Re-Stem Biotech website: https://www.restembio.com/

Forward-Looking StatementsStatements in this press release relating to plans, strategies, trends, specific activities or investments, and other statements that are not descriptions of historical facts and may be forward-looking statements are inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include those regarding our ability to implement objective, plans and strategies for future operations. Forward-looking information may be identified by terms such as "will," "may," "expects," "plans," "intends," "estimates," "potential," or "continue," or similar terms or the negative of these terms. Although Re-Stem believes the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that future results, performance or achievements will be obtained. Re-Stem does not have any obligation to update these forward-looking statements other than as required by law.

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Could EPO be used to treat COVID-19? – Canadian Running Magazine

By daniellenierenberg

After case studies of COVID-19, researchers from the Max Planck Institute of Experimental Medicine in Gttingen, Germany, believe that erythropoietin (EPO) could be used to treat COVID-19 patients. A go-to for many dopers in endurance sports, EPO stimulates the production of red blood cells, which can help with oxygen supply in a users brain and muscles. The team of Mac Planck researchers are planning a clinical trial to take a more in-depth look at EPO and its effects on the coronavirus, and they have outlined their reasoning in an articleon the institutes website.

The German team of researchers cite a COVID-19 case from Iran which occurred in March. The patient was infected with the coronavirus, but doctors noted that they also had poor blood values. To combat this, the patient was prescribed EPO in addition to the regular care for COVID-19. Just a week after starting the EPO treatment, the patient was well enough to return home.

RELATED: Ottawa Marathon third-place finisher provisionally suspended for EPO

Researchers also point to South American populations that live at high altitudes, where severe illnesses are rarer than in lower regions. The Mac Planck Institute team writes that this may be because people living at higher altitudes form more EPO and are better adapted to oxygen deficiency because they have more red blood cells.

According to the article, experiments on animals have shown that EPO affectsparts of the brain stem and spinal cord that control breathing. As a result, the researchers write, breathing improves when there is an oxygen deficiency. EPO also has an anti-inflammatory effect on immune cells and could thus attenuate the frequently exaggerated immune response in COVID-19 patients.

RELATED: WADA to fund anti-doping project piloting artificial intelligence

Dr. Hannelore Ehrenreich, one of the researchers on the German team, notes the importance of determining whether EPO could be an effective treatment for the coronavirus.

Because COVID-19 can have such severe health-related consequences, we must investigate any evidence of a protective effect of EPO, Ehrenreich says. After all, there is currently neither a vaccine nor a medication for the disease. We are therefore preparing a proof-of-concept study to investigate the effect of EPO on COVID-19 in humans. The clinical trial will see severely ill COVID-19 patients receiving EPO to see if it can alleviate severe disease progression.

RELATED: More than half of Bahrains athletics medals are tainted by doping scandals

Following the release of the Max Planck article, running coach Steve Magness tweeted, Just waiting for some athlete or coach trying to get a TUE for taking EPO for a mild COVID case. TUE stands for Therapeutic Use Exemption, which allows athletes to use banned substances for legitimate medical reasons. Magnesss tweet had the feel of a joke, but theres a ring of truth to it. Dopers will do a lot to get away with cheating, and if using EPO to treat COVID-19 becomes a widespread treatment, some athletes might actually take advantage of it.

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Revenue from the Sales of Neuroprosthetics Market to Increase Exponentially During 2015 2021 – 3rd Watch News

By daniellenierenberg

Central nervous system comprises brain and spinal cord, and is responsible for integration of sensory information. Brain is the largest and one of the most complex organs in the human body. It is made up of 100 billion nerves that communicate with 100 trillion synapses. It is responsible for the thought and movement produced by the body. Spinal cord is connected to a section of brain known as brain stem and runs through the spinal canal. The brain processes and interprets sensory information sent from the spinal cord. Brain and spinal cord serve as the primary processing centers for the entire nervous system, and control the working of the body. Neuroprosthetics improves or replaces the function of the central nervous system. Neuroprosthetics, also known as neural prosthetics, are devices implanted in the body that stimulate the function of an organ or organ system that has failed due to disease or injury. It is a brain-computer interface device used to detect and translate neural activity into command sequences for prostheses. Its primary aim is to restore functionality in patients suffering from loss of motor control such as spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis, and stroke. The major types of neuroprosthetics include sensory implants, motor prosthetics, and cognitive prosthetics. Motor prosthetics support the autonomous system and assist in the regulation or stimulation of affected motor functions.

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Similarly, cognitive prosthetics restore the function of brain tissue loss in conditions such as paralysis, Parkinsons disease, traumatic brain injury, and speech deficit. Sensory implants pass information into the bodys sensory areas such as sight or hearing, and it is further classified as auditory (cochlear implant), visual, and spinal cord stimulator. Some key functions of neuroprosthetics include providing hearing, seeing, feeling abilities, pain relief, and restoring damaged brain cells. Cochlear implant is among the most popular neuroprosthetics. In addition, auditory brain stem implant is also a neuroprosthetic meant to improve hearing damage.

North America dominates the global market for neuroprosthetics due to the rising incidence of neurological diseases and growth in geriatric population in the region. Asia is expected to display a high growth rate in the next five years in the global neuroprosthetics market, with China and India being the fastest growing markets in the Asia-Pacific region. Among the key driving forces for the neuroprosthetics market in developing countries are the large pool of patients, increasing awareness about the disease, improving healthcare infrastructure, and rising government funding in the region.

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Increasing prevalence of neurological diseases such as traumatic brain injury, stroke and Parkinsons disease, rise in geriatric population, increase in healthcare expenditure, growing awareness about healthcare, rapid progression of technology, and increasing number of initiatives by various governments and government associations are some key factors driving growth of the global neuroprosthetics market. However, factors such as high cost of devices, reimbursement issues, and adverse effects pose a major restraint to the growth of the global neuroprosthetics market.

Innovative self-charging neural implants that eliminate the need for high risk and costly surgery to replace the discharge battery and controlling machinery with thoughts would help to develop opportunities for the growth of the global neuroprosthetics market. The major companies operating in the global neuroprosthetics market are Boston Scientific Corporation, Cochlear Limited, Medtronic, Inc., Cyberonics, Inc., NDI Medical LLC, NeuroPace, Inc., Nervo Corp., Retina Implant AG, St. Jude Medical, and Sonova Group.

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Growing population and economies in the developing countries such as India and China are expected to drive growth of the prosthetic heart valves market in Asia. In addition, introduction of innovative products with technological advancements, increasing demand for minimally-invasive devices, and rise in incidences of cardiac valve disorders are expected to create opportunities for the global prosthetic heart valves market. Increasing number of mergers and acquisitions, rise in the number of collaborations and partnerships, and product launches are some of the latest trends in the global prosthetic heart valves market.Some of the major companies operating in the global prosthetic heart valves market are Edwards Lifesciences, Medtronic, Abbott Laboratories,ON-X LIFE TECHNOLOGIES, INC.,and St. Jude Medical.In addition, some of the other companies operating in the global prosthetic heart valves market are Sorin Group, CryoLife, LepuMedical, and Braile Biomedica, Ltda.

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Revenue from the Sales of Neuroprosthetics Market to Increase Exponentially During 2015 2021 - 3rd Watch News

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COVID-19 impact on Spinal Fusion Market Growth Analysis, Demand by Regions and Global Forecasts To 2025 | Charter, Worthington Industries, Cesca…

By daniellenierenberg

Spinal Fusion Market 2020: Latest Analysis

Chicago, United States:-TheSpinal Fusion market report5 Years Forecast [2020-2025]focuses on theCOVID19 Outbreak Impact analysis of key points influencing the growth of the market. The research report on the Spinal Fusion Market is a deep analysis of the market. This is a latest report, covering the current COVID-19 impact on the Spinal Fusion market. The pandemic of Coronavirus (COVID-19) has affected every aspect of life globally. This has brought along several changes in market conditions. The rapidly changing market scenario and initial and future assessment of the impact is covered in the report. Experts have studied the historical data and compared it with the changing market situations. The report covers all the necessary information required by new entrants as well as the existing players to gain deeper insight.

Furthermore, the statistical survey in the report focuses on product specifications, costs, production capacities, marketing channels, and market players. Upstream raw materials, downstream demand analysis, and a list of end-user industries have been studied systematically, along with the suppliers in this market. The product flow and distribution channel have also been presented in this research report.

Top Players of Spinal Fusion Market are studied:CharterWorthington IndustriesCesca TherapeuticsShengjie Cryogenic EquipmentSichuan mountain verticalQingdao Beol

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Note: Covid-19 pandemic affects most industries in the globe. Here at acquire market research we offer you comprehensive data of related industry which will help and support your business in all possible ways.Due to the pandemic of COVID-19 businesses have seen a decrease in their profits. While our intention is to help businesses regain their profits we also provide information regarding the COVID-19 virus to help our customers stay safe during the pandemic

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The analysis includes market size, upstream situation, market segmentation, market segmentation, price & cost and industry environment. In addition, the report outlines the factors driving industry growth and the description of market channels.The report begins from overview of industrial chain structure, and describes the upstream. Besides, the report analyses market size and forecast in different geographies, type and end-use segment, in addition, the report introduces market competition overview among the major companies and companies profiles, besides, market price and channel features are covered in the report.

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Our exploration specialists acutely ascertain the significant aspects of the global Spinal Fusion market report. It also provides an in-depth valuation in regards to the future advancements relying on the past data and present circumstance of Spinal Fusion market situation. In this Spinal Fusion report, we have investigated the principals, players in the market, geological regions, product type, and market end-client applications. The global Spinal Fusion report comprises of primary and secondary data which is exemplified in the form of pie outlines, Spinal Fusion tables, analytical figures, and reference diagrams. The Spinal Fusion report is presented in an efficient way that involves basic dialect, basic Spinal Fusion outline, agreements, and certain facts as per solace and comprehension.

Table of Contents.

Report Overview:It includes major players of the globalkeywordmarket covered in the research study, research scope, and market segments by type, market segments by application, years considered for the research study, and objectives of the report.

Global Growth Trends:This section focuses on industry trends where market drivers and top market trends are shed light upon. It also provides growth rates of key producers operating in the globalkeywordmarket. Furthermore, it offers production and capacity analysis where marketing pricing trends, capacity, production, and production value of the globalkeywordmarket are discussed.

Market Share by Manufacturers:Here, the report provides details about revenue by manufacturers, production and capacity by manufacturers, price by manufacturers, expansion plans, mergers and acquisitions, and products, market entry dates, distribution, and market areas of key manufacturers.

Market Size by Type:This section concentrates on product type segments where production value market share, price, and production market share by product type are discussed.

Market Size by Application:Besides an overview of the globalkeywordmarket by application, it gives a study on the consumption in the globalkeywordmarket by application.

Production by Region:Here, the production value growth rate, production growth rate, import and export, and key players of each regional market are provided.

Consumption by Region:This section provides information on the consumption in each regional market studied in the report. The consumption is discussed on the basis of country, application, and product type.

Company Profiles:Almost all leading players of the globalkeywordmarket are profiled in this section. The analysts have provided information about their recent developments in the globalkeywordmarket, products, revenue, production, business, and company.

Market Forecast by Production:The production and production value forecasts included in this section are for the globalkeywordmarket as well as for key regional markets.

Market Forecast by Consumption:The consumption and consumption value forecasts included in this section are for the globalkeywordmarket as well as for key regional markets.

Value Chain and Sales Analysis:It deeply analyzes customers, distributors, sales channels, and value chain of the globalkeywordmarket.

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COVID-19 impact on Spinal Fusion Market Growth Analysis, Demand by Regions and Global Forecasts To 2025 | Charter, Worthington Industries, Cesca...

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Lineage Cell Therapeutics Is A High-Risk But High-Reward Opportunity To Consider – Seeking Alpha

By daniellenierenberg

Lineage Cell Therapeutics (LCTX) is a small biotech developing 3 different off-the-shelf cell therapy products in dry AMD, spinal cord injuries, and non-small cell lung cancer. These are large unmet medical needs and have attracted interest from third-party groups that have provided some funding to advance Lineages programs. Currently valued at just under $125 million, Lineage could clearly have a huge upside if these programs make it to market. This article provides my assessment of why Lineage is worth the risk at present.

Lineages main pipeline asset is OpRegen which is being developed to treat dry age-related macular degeneration. Dry AMD is a huge market opportunity. One market estimate Ive seen is that the dry AMD market was worth approximately $2.09 billion in 2017 and that the overall growth rate of the AMD market (both dry and wet AMD) as a whole is expected to be around 7.8% in the coming years. It's likely this growth rate understates dry AMD growth potential in particular given the relative lack of treatment options for dry AMD as compared to wet AMD.

According to Lineage, this estimate is likely way under what the true market size could be, too. Lineage says the wet AMD market is greater than $10 billion yet dry AMD represents about 90% of the total cases.

Figure 1: Lineages Dry AMD Competition (source: corporate presentation)

Apellis (APLS) has a Phase 3 candidate for dry AMD that, if successful, will likely hit the market before OpRegen. In addition, there are a couple other potential therapies that are more early-stage products. As you can see from Figure 1 though, OpRegen should stack up pretty well if Lineage can continue to successfully develop the product.

OpRegen utilizes Lineages technology platform of off-the-shelf pluripotent stem cells.

Figure 2: Lineages Technology Platform (source: corporate presentation)

In the case of OpRegen, Lineage is using these pluripotent stem cells to create retinal pigment epithelium cells that are injected into the eye to replace those lost due to disease. This should support photoreceptors that otherwise would have lost function due to disease progression, causing decreased levels of vision and eventually blindness over time in severe cases.

Figure 3: OpRegen Mechanism of Action (source: corporate presentation)

Lineage has an ongoing Phase 1/2a trial that is close to full enrollment, lacking just 3 patients now. Enrollment was temporarily paused due to the COVID-19 pandemic, but the company has re-initiated patient enrollment and hopes to have complete enrollment later this quarter (Q3). Lineage also recently reported that 1 of the 18 patients enrolled to date has already shown signs of retinal tissue regeneration, a first-in-human clinical result.

Although very early, this type of progress is encouraging, and its clear that the market potential is huge if Lineage can make it to the finish line. Investors should be aware though that a major setback in a lead program like OpRegen could be devastating to Lineage and its shareholders.

Lineages Other 2 Pipeline Programs Have Received Third-Party Funding and Similarly Address Large Market Needs

In addition to OpRegen, Lineage has 2 other potentially lucrative products in its pipeline.

Figure 4: Lineages Pipeline (source: Lineages website)

The one that is furthest along after OpRegen is OPC1 for spinal cord injury. Spinal cord trauma was a $2.27 billion market in 2017 and is expected to grow at 3.7% per year. Unfortunately for patients affected, there are no current treatments on the market that affect disease progression or reversal of the traumatic damage, but by contrast, OPC1 is intended to actually improve the function of a patients upper extremities.

Lineage uses its pluripotent stem cell technology to create oligodendrocyte progenitor cells and injects them into the area of the spinal injury. This hopefully allows for re-myelination at the injury site and increased nerve and blood vessel growth in the area. A Phase 1 and a Phase 1/2a trial have already been completed with promising results. Although obviously just one anecdotal case, Lineage has shared the story of 1 clinical trial patient going from complete paralysis to throwing out the first pitch at a baseball game.

Figure 5: Results of 1 OPC1 Trial Participant (source: Lineages website)

Lineage is in the process of evaluating this trial data and plans as a next step to have a meeting with the FDA about proceeding with a Phase 2/3 trial.

Lineages last pipeline asset is VAC2, which is a potential dendritic cell-based cancer vaccine that has received support from Cancer Research UK. The underlying VAC platform could potentially be used for both cancers and infectious diseases based on what type of antigen is loaded into the cells before injection into the body. The first targeted indication is in non-small cell lung cancer, for which there is already an ongoing Phase 1 trial. Interim Phase 1 data should be available in Q4. Upon receiving positive results, Lineage intends to try using VAC2 in conjunction with an immune checkpoint inhibitor in a Phase 2 trial.

A couple years back, the 20th drug on the list of best-selling anti-cancer agents still brought in $960 million and the 1st brought in $6.7 billion. That market is already larger now and will be even more so by the time Lineages therapy might hit the market because the estimated CAGR is around 7.6%. Non-small cell lung cancer in particular is estimated to be a $10.9 billion market next year and is notoriously hard to treat.

Also noteworthy is that Lineage has said it is investigating using its VAC platform for a potential COVID-19 vaccine. Lineage is reportedly seeking grant funding to continue this program. It seems like a long-shot for Lineage to get meaningfully involved in this effort well after many other better-funded companies, but I am glad to see that Lineage intends to use grant funding to pursue this opportunity rather than its own resources if there is funding to be had.

Lineage reported having $9.8 million in cash and $15.9 million in marketable securities as of the end of Q1. These marketable securities include stakes in OncoCyte (OCX), AgeX (AGE), and Hadasit. Lineage also holds a $24 million promissory note from Juvenescence that matures this August, but this note automatically converts to Juvenescence securities in the event of an IPO by Juvenescence before then.

Lineage has no long-term debt and reported an $8.4 million loss in Q1. This level of cash burn implies that Lineage can only make it to around the end of this year on its cash and securities alone. Lineage should get liquidity on its promissory note from Juvenescence later this year whether through repayment or an IPO. This will buy Lineage until late next year at current levels of spending.

I think its also worth noting that there is certainly a risk that the value of Lineages marketable securities will decline resulting in Lineage getting less cash from an eventual sale. For example, just this week OncoCyte reported that its lung nodule liquid biopsy failed and the stock tanked about 40%. Lineages remaining Oncocyte holdings are now worth only about $8.2 million rather than the $11.3 million estimated value reported at the end of Q1. Lineage may find it has far less cash available than expected if similar things keep happening.

Regardless, a company like Lineage will have to sell a large amount of its own stock to raise cash before its therapies will ever even have a chance of hitting the market. Lineages current stock price would make this means of funding inefficient and highly dilutive. Lineage investors need to be aware that major setbacks to its pipeline at this stage could result in the loss of most, if not all, invested capital.

I first analyzed future revenue and earnings estimates to assess Lineages value proposition. There were only 2 analyst estimates posted for most years over the next decade this is less than I would like to see but still a good starting point since these 2 analysts estimates are reasonably similar.

Figure 6: Lineage Sales and Earnings Estimates (source: Seeking Alpha)

As you can see from Figure 6, once Lineage is estimated to be cash-flow positive in 2023, its sales and earnings ratios become extremely low. Im not sure I can recall analyzing a company that was trading at less than .2x estimated future earnings when 15x is about average. I then discounted these estimates to see how the ratios changed.

Figure 7: Lineage Present Value Estimates (source: sales and earnings estimates from Seeking Alpha and my calculations based on them)

Even at an extremely high 30% discount rate to factor in the risky, early-stage nature of Lineage's pipeline, Lineage shares have roughly 2.5x upside to the present value estimate I calculated at an average 5 P/S and about 4.5x upside to my present value estimate calculated at an average 15 P/E. These are strongly suggestive that Lineage is undervalued. Despite this, given how early-stage and unproven as Lineages therapies are, I wanted to conduct a discounted cash flow analysis to see if it would confirm that Lineage shares provide a good risk/reward balance.

I estimated SG&A expenses as 34% of revenue, marketing expense at 5% of revenue, and cost of goods sold at 10%, at the point where the company has substantial cash flow in a few years, and I scale the numbers up fairly evenly from present values for the years in between. I also adjusted for future cash flow needs based on continuing cash burn for the foreseeable future. I used the market size estimates as described above for each of Lineages potential dry AMD and spinal cord trauma therapies, and for the potential cancer therapy, I modeled it as having peak sales equivalent to what would put it just barely in the top 20 of best-selling cancer drugs, albeit scaled up for expected overall market growth.

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Figure 8: Lineage Discounted Cash Flow Analysis (source: Lineages 10-Q and my calculations based on it)

As you can see in Figure 8, my model shows a potential fair value of $1.69 per share, which is over 80% above where Lineage is currently trading. In my view, this analysis, in combination with the sales and earnings estimates in Figure 7, shows that Lineage does present a relatively good risk/reward opportunity for long-term investors at current price levels. I recently added a small speculative position in Lineage stock to my portfolio, and I intend to hold on to most of the position long term, absent a substantial change to the companys outlook.

Lineage is targeting disease indications that are big, unmet market needs, but each pipeline therapy is still very early. Any potential investor should note that an investment in Lineage comes with a very real possibility of the loss of the entire investment if Lineages technology proves unsuccessful. That being said, I view the risk/reward as a decent bet at current price levels and have initiated a small position myself.

Disclosure: I am/we are long LCTX. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Additional disclosure: Im not a registered investment advisor. Despite that I strive to provide the most accurate information, I neither guarantee the accuracy nor the timeliness. Past performance does NOT guarantee future results. I reserve the right to make any investment decision for myself without notification. The thesis that I presented may change anytime due to the changing nature of information itself. Investment in stocks and options can result in a loss of capital. The information presented should NOT be construed as a recommendation to buy or sell any form of security. My articles are best utilized as educational and informational materials to assist investors in your own due diligence process. You are expected to perform your own due diligence and take responsibility for your actions. You should also consult with your own financial advisor for specific guidance as financial circumstances are individualized.

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Lineage Cell Therapeutics Is A High-Risk But High-Reward Opportunity To Consider - Seeking Alpha

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