KUANTAN, Malaysia Some skin, eggs and tissue samples are all that remain of Malaysia's last rhino, Iman, who died last November after years of failed breeding attempts.

Now scientists are pinning their hopes on experimental stem cell technology to bring back the Malaysian variant of the Sumatran rhinoceros, making use of cells from Iman and two other dead rhinos.

"I'm very confident," molecular biologist Muhammad Lokman Md Isa told Reuters in his laboratory at the International Islamic University of Malaysia.

"If everything is functioning, works well and everybody supports us, it's not impossible."

The smallest among the world's rhinos, the Sumatran species was declared extinct in the wild in Malaysia in 2015. Once it had roamed across Asia, but hunting and forest clearance reduced its numbers to just 80 in neighbouring Indonesia.

Iman, 25, died in a nature reserve on Borneo island, following massive blood loss caused by uterine tumours, within six months of the death of Malaysia's last male rhino, Tam.

Efforts to get the two to breed had not worked.

"He was the equivalent of a 70-year-old man, so of course you don't expect the sperm to be all that good," said John Payne of the Borneo Rhino Alliance (BORA), who has campaigned for about four decades to save Malaysia's rhinos.

"It was obvious that, to increase the chances of success, one should get sperm and eggs from the rhinos in Indonesia. But right till today, Indonesia is still not keen on this."

ACROSS THE BORDER

Indonesia's environment ministry disputed accusations of cross-border rivalry as a reason why Malaysia's rhinos died out, saying talks continue on ways to work with conservationists in the neighbouring southeast Asian nation.

"Because this is part of diplomatic relations, the implementation must be in accordance with the regulation of each country," said Indra Exploitasia, the ministry's director for biodiversity conservation.

The Malaysian scientists plan to use cells from the dead rhinos to produce sperm and eggs that will yield test-tube babies to be implanted into a living animal or a closely related species, such as the horse.

The plan is similar to one for the African northern white rhinoceros, which number just two. Researchers in that effort reported some success in 2018 in producing embyronic stem cells for the southern white rhino.

But the process is still far from producing a whole new animal, say Thomas Hildebrandt and Cesare Galli, the scientists leading the research.

And even if it worked, the animals' lack of genetic diversity could pose a threat to long-term survival, Galli told Reuters.

Indonesian scientist Arief Boediono is among those helping in Malaysia, hoping success will provide lessons to help his country's rhinos.

"It may take five, 10, 20 years, I don't know," Arief added. "But there has already been some success involving lab rats in Japan, so that means there is a chance."

Japanese researchers have grown teeth and organs such as pancreas and kidneys using embryonic stem cells from rats and mice in efforts to grow replacement human organs.

For now, however, Iman's hide will be stuffed and put on display alongside Tam in a Borneo museum.

(Editing by Matthew Tostevin and Clarence Fernandez)

Originally posted here:
Back From the Dead? Stem Cells Give Hope for Revival of Malaysia's Extinct Rhinos - The New York Times

Skin Stem Cells Comments Off on Back From the Dead? Stem Cells Give Hope for Revival of Malaysia’s Extinct Rhinos – The New York Times | August 12th, 2020

After months of reviewing close to 300 beauty products and wellness facilities, and tallying, here are the best skincare products of this year, and lest we forget, your top pick! And so without further ado, here are the Beauty & Wellness Awards winners.

As technology continues to advance and discoveries are made each day,we do our part in dipping our toe in the proverbial pool of beauty toexplore the latest and greatest. Embracing the new is part of our job asinvestigative beauty aficionados, and as we dig through the recentdebuts, weve found some newbies that have found a permanent spot onour top shelf that we highly recommend checking out.

1

Best Face Cream: First Aid Beauty Ultra Repair Cream

For even the most sensitive skin, FAB delivers animpressive amount of hydration without anyirritation. The luscious whipped-cream texturespreads easily over the face, yet still holds wellenough for make-up to sit over nicely.

Ultra Repair Cream

HK$249/170g; HK$109/56.7G

2

Best Hydrating Serum: Skin Need 100% Hyaluronic Acid B5

The ultimate water magnet, thisserum locks in all the hydration youneed. Its easily absorbed, so yourskin feels fresh and clean without atrace of stickiness. The heavy doseof hyaluronic acid binds and trapsmoisture to the skin.

100% Hyaluronic Acid B5

HK$598

3

Best Reparative Formula: Wildsmith Skin Active Repair Radiance Polisher

Exfoliate to your hearts content and skinsneed the gentle grains of walnut shell androsehip-seed powder sloughs away deadskin cells and polishes the skins surface. Mixthe desired amount with any facial cleanserto create your very own scrub.

Skin Active Repair Radiance Polisher

HK$254

4

Best Body Cream: Augustinus Bader The Body Cream

A fresh launch from world-leadingstem cell and biomedical pioneerand scientist, Professor AugustinusBader, The Body Cream is officiallythe newest must-have item in bodyand skin care. Powered by thebrands patented Trigger FactorComplex (TFC8), this cellularrenewal cream reawakens dormantstem cells and results in firmer,toned skin with a reduction incellulite and stretch marks.

5

Readers Choice: Drunk Elephant F-balm

Electrolytes pump us full of hydration. And if its good to ingest. Why wouldnt it be topically? This waterfacial masque hydratant nourishes and repairs parched skin while you sleep. Its cooling effects are especially appreciated this season.

All of the Drunk Elephant products are naturally formulated and cater directly to your skins health. Oi Tak Kan, Prestige Reader

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Beauty & Wellness Awards 2020: New Kids on the Block - Prestige Online

Skin Stem Cells Comments Off on Beauty & Wellness Awards 2020: New Kids on the Block – Prestige Online | August 12th, 2020

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Going On At The Greenville Library - WSPA 7News

Skin Stem Cells Comments Off on Going On At The Greenville Library – WSPA 7News | August 12th, 2020

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.

See the article here:
Stem Cell Grafts Show Functionality in Spinal Cord Injuries

Spinal Cord Stem Cells Comments Off on Stem Cell Grafts Show Functionality in Spinal Cord Injuries | August 12th, 2020

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

Spinal Cord Stem Cells Comments Off on Repairing damage caused by spinal cord injury with stem cells | August 12th, 2020

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.

Original post:
Implanted Neural Stem Cell Grafts Show Functionality in ...

Spinal Cord Stem Cells Comments Off on Implanted Neural Stem Cell Grafts Show Functionality in … | August 12th, 2020

According to latest research report on Global Stem Cell Banking Market report provides information related to market size, production, CAGR, gross margin, growth rate, emerging trends, price, and other important factors. Focusing on the key momentum and restraining factors in this market, the report also provides a complete study of future trends and developments in the market.

The Stem Cell Banking report contains all the details of the expected market dynamics and new market opportunities due to the COVID-19 outbreak. Stratagem Market Insights tried to cover all the market analysis of annual economic growth in the latest report on the Stem Cell Banking market.

According to analysts, the growth of the Stem Cell Banking market will have a positive impact on the global platform and will witness gradual growth over the next few years. This report study incorporates all the market growth and restraining factors along with the important trends mentioned between 2020 and 2025.

Request Sample Copy of this Report @ https://www.express-journal.com/request-sample/167802

Market segmentation:

The Stem Cell Banking market has been segmented into a variety of essential industries including applications, types, and regions. In the report, each market segment is studied extensively, taking into account market acceptance, value, demand, and growth prospects. Segmentation analysis allows customers to customize their marketing approach to make better orders for each segment and identify the most potential customers.

Global Stem Cell Banking Market Segmentation by Application:

Global Stem Cell Banking Market Segmentation by Product:

Competitive Landscape

This section of the report identifies various major manufacturers in the market. It helps readers understand the strategies and collaborations players are focusing on fighting competition in the marketplace. The comprehensive report gives a microscopic view of the market. The reader can identify the manufacturers footprint by knowing about the manufacturers global revenue, the manufacturers global price, and the manufacturers production during the forecast period.

The major manufacturers covered in this report:

Regional Insights of Stem Cell Banking Market:

In terms of geography, this research report covers almost all major regions around the world such as North America, Europe, South America, Middle East, Africa, and the Asia Pacific. Europe and North America are expected to increase over the next few years. Stem Cell Banking markets in the Asia-Pacific region are expected to experience significant growth during the forecast period. Advanced technology and innovation are the most important characteristics of North America and the main reason why the United States dominates the world market. The Stem Cell Banking market in South America is also expected to expand in the near future.

Years considered for this report:

Important Facts about Stem Cell Banking Market Report:

Questions Answered by the Report:

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Stem Cell Banking Market Applications, Types and Future Outlook Report 2020-2025 - Express Journal

Bone Marrow Stem Cells Comments Off on Stem Cell Banking Market Applications, Types and Future Outlook Report 2020-2025 – Express Journal | August 12th, 2020

TEL AVIV, Israel, Aug. 12, 2020 /PRNewswire/ -- Cellect Biotechnology Ltd. (NASDAQ: APOP), a developer of innovative technology which enables the functional selection of stem cells, today reported financial and operating results for the second quarter ended June 30, 2020. The Company's six-month progress includes the development of several strategic initiatives, including growth-oriented opportunities in pain management and COVID-19 related therapeutics.

"Despite the COVID-19 pandemic business disruptions and the near-term delays to completing and commencing our clinical programs in Israel and the U.S., respectively, we acted swiftly over the past few months to leverage our sought-after technology to create several long-term business initiatives to enhance our value," commented Dr. Shai Yarkoni, Chief Executive Officer. "In addition to pursuing a potential merger with a global leader in the high growth medical-grade cannabis market, which is being delayed due to COVID-19, we have either initiated or are contemplating other business development activities that will greatly benefit from our innovation, technology and know-how. I believe each of these opportunities represents meaningful catalysts for Cellect in multi-billion-dollar markets, subject to resolution of the COVID-19 pandemic and return to normal course of business."

Notwithstanding the continued delays due to COVID-19, the Company remains focused on the following operational and clinical objectives:

The Company's cash and cash equivalents totaled $7 million as of June 30, 2020, which includes the approximately $1.5 million (gross before expenses)resulting from several investors exercising certain warrants that were issued in February 2019.

SecondQuarter 2020 Financial Results:

*For the convenience of the reader, the amounts above have been translated from NIS into U.S. dollars, at the representative rate of exchange on June 30, 2020 (U.S. $1 = NIS 3.466).

About Cellect Biotechnology Ltd.

Cellect Biotechnology (APOP) has developed a breakthrough technology, for the selection of stem cells from any given tissue, that aims to improve a variety of stem cell-based therapies.

The Company's technology is expected to provide researchers, clinical community and pharma companies with the tools to rapidly isolate stem cells in quantity and quality allowing stem cell-based treatments and procedures in a wide variety of applications in regenerative medicine. The Company's current clinical trial is aimed at bone marrow transplantations in cancer treatment.

Forward Looking Statements

This press release contains forward-looking statements about the Company's expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. For example, forward-looking statements are used in this press release when we discuss Cellect's expectations regarding timing of the commencement of its planned U.S. clinical trial and its plan to reduce operating costs. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: the Company's history of losses and needs for additional capital to fund its operations and its inability to obtain additional capital on acceptable terms, or at all; the Company's ability to continue as a going concern; uncertainties of cash flows and inability to meet working capital needs; the Company's ability to obtain regulatory approvals; the Company's ability to obtain favorable pre-clinical and clinical trial results; the Company's technology may not be validated and its methods may not be accepted by the scientific community; difficulties enrolling patients in the Company's clinical trials; the ability to timely source adequate supply of FasL; risks resulting from unforeseen side effects; the Company's ability to establish and maintain strategic partnerships and other corporate collaborations; the scope of protection the Company is able to establish and maintain for intellectual property rights and its ability to operate its business without infringing the intellectual property rights of others; competitive companies, technologies and the Company's industry; unforeseen scientific difficulties may develop with the Company's technology; the Company's ability to retain or attract key employees whose knowledge is essential to the development of its products; and the Company's ability to pursue any strategic transaction or that any transaction, if pursued, will be completed. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in Cellect Biotechnology Ltd.'s Annual Report on Form 20-F for the fiscal year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, http://www.sec.gov, and in the Company's periodic filings with the SEC.

Cellect Biotechnology Ltd.

Consolidated Statement of Operation

Convenience

translation

Six months

ended

Six months ended

Three months ended

June 30,

June 30,

June 30,

2020

2020

2019

2020

2019

Unaudited

Unaudited

U.S. dollars

NIS

(In thousands, except share and per

share data)

Research and development expenses

837

2,901

7,086

1,364

3,564

General and administrative expenses

1,356

4,703

5,064

2,116

2,709

Operating loss

2,193

7,604

12,150

3,480

6,273

Financial expenses (income) due to warrants exercisable into shares

1,098

3,807

(7,111)

4,697

(5,919)

Other financial expenses (income), net

(15)

(55)

880

627

462

Total comprehensive loss

3,276

11,356

5,919

8,804

816

Loss per share:

Basic and diluted loss per share

0.010

0.034

0.029

0.024

0.004

Weighted average number of shares outstanding used to compute basic and diluted loss per share

338,182,275

338,182,275

200,942,871

365,428,101

224,087,799

Cellect Biotechnology Ltd.

Consolidated Balance Sheet Data

Convenience

translation

June 30,

June 30,

December 31,

2020

2020

2019

Unaudited

Unaudited

Audited

U.S. dollars

NIS

(In thousands, except share and per

share data)

CURRENT ASSETS:

See the article here:
Cellect Biotechnology Reports Second Quarter Financial and Operating Results; First Half 2020 Strategic Developments Create Long-Term Revenue...

Bone Marrow Stem Cells Comments Off on Cellect Biotechnology Reports Second Quarter Financial and Operating Results; First Half 2020 Strategic Developments Create Long-Term Revenue… | August 12th, 2020

DUBLIN, Aug. 11, 2020 /PRNewswire/ -- The "Global Induced Pluripotent Stem Cell (iPS Cell) Industry Report" report has been added to ResearchAndMarkets.com's offering.

Since the discovery of induced pluripotent stem cells (iPSCs) a large and thriving research product market has grown into existence, largely because the cells are non-controversial and can be generated directly from adult cells. It is clear that iPSCs represent a lucrative market segment because methods for commercializing this cell type are expanding every year and clinical studies investigating iPSCs are swelling in number.

Therapeutic applications of iPSCs have surged in recent years. 2013 was a landmark year in Japan because it saw the first cellular therapy involving the transplant of iPSCs into humans initiated at the RIKEN Center in Kobe, Japan. Led by Masayo Takahashi of the RIKEN Center for Developmental Biology (CDB), it investigated the safety of iPSC-derived cell sheets in patients with macular degeneration. In another world-first, Cynata Therapeutics received approval in 2016 to launch the world's first formal clinical trial of an allogeneic iPSC-derived cell product (CYP-001) for the treatment of GvHD. Riding the momentum within the CAR-T field, Fate Therapeutics is developing FT819, its off-the-shelf iPSC-derived CAR-T cell product candidate. Numerous physician-led studies using iPSCs are also underway in Japan, a leading country for basic and applied iPSC applications.

iPS Cell Commercialization

Methods of commercializing induced pluripotent stem cells (iPSCs) are diverse and continue to expand. iPSC cell applications include, but are not limited to:

Since the discovery of iPSC technology in 2006, significant progress has been made in stem cell biology and regenerative medicine. New pathological mechanisms have been identified and explained, new drugs identified by iPSC screens are in the pipeline, and the first clinical trials employing human iPSC-derived cell types have been initiated. The main objectives of this report are to describe the current status of iPSC research, patents, funding events, industry partnerships, biomedical applications, technologies, and clinical trials for the development of iPSC-based therapeutics.

Key Topics Covered:

1. Report Overview

2. Introduction

3. History of Induced Pluripotent Stem Cells (IPSCS)

4. Research Publications on IPSCS

5. IPSCS: Patent Landscape

6. Clinical Trials Involving IPSCS

7. Funding for IPSC

8. Generation of Induced Pluripotent Stem Cells: An Overview

9. Human IPSC Banking

10. Biomedical Applications of IPSCS

11. Other Novel Applications of IPSCS

12. Deals in the IPSCS Sector

13. Market Overview

14. Company Profiles

For more information about this report visit https://www.researchandmarkets.com/r/kpc95y

About ResearchAndMarkets.comResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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Opportunities in the Global Induced Pluripotent Stem Cell (iPS Cell) Industry - PRNewswire

IPS Cell Therapy Comments Off on Opportunities in the Global Induced Pluripotent Stem Cell (iPS Cell) Industry – PRNewswire | August 11th, 2020

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

Spinal Cord Stem Cells Comments Off on New Study Presents Cell-based Therapy for MN Diseases or Spinal Cord Disorders – Mirage News | August 11th, 2020

With the help of a huge 66M Series A round last week, the German startup T-knife is developing cancer T-cell immunotherapies with the help of genetically modified mice. However, this is just one of several cancer T-cell therapy startups making advances this year, with other innovations including off-the-shelf treatments and a potential universal cancer therapy.

The rise of Chimeric Antigen Receptor (CAR) T-cell immunotherapy was a major step forward in the treatment of cancer. CAR T-cell therapy consists of bioengineering a patients immune T cells to produce proteins called CARs. These proteins recognize targets on the surface of cancer cells, letting the T-cells destroy them. However, CAR T-cell therapy is also limited against solid tumors since many cancer targets lie within the cancer cells, beyond the reach of the CAR proteins.

In the last few months, European startups have been making advances in T-cell receptor (TCR) T-cell immunotherapies, which could be better than CAR T-cells at hunting down solid tumors. This is because the protein that is genetically modified on TCR T cells the TCR can recognize targets hidden inside cancer cells by scanning a protein on the cell surface called human leukocyte antigen (HLA).

Last week, the Berlin-based T-knife brought TCR T-cell therapies into the spotlight with a huge 66M Series A round. With the proceeds, the startup aims to take a radical approach to developing TCR T-cell therapies.

While most TCR T-cell therapy developers tweak existing human TCRs in their cell therapies, T-knife sources its cancer-hunting TCRs from mice. The firm genetically modifies mice to produce fully humanized T-cell receptors and injects them with human tumor antigens. The immune system of the mice then reacts to the cancer antigens and produces a variety of T-cell receptors. After picking the best cancer-seeking T-cell receptors from the mouse immune system, T-knife then expresses them in the patients T cells to produce the cell therapy.

The mouse immune system is not tolerant of human tumor antigens it sees them like a virus or a pathogen. Thus we can generate a strong immune response in the mice when we immunize them with human tumor antigens, Elisa Kieback, CEO and co-founder of T-knife, told me.

According to Kieback, the companys mouse-derived TCRs can latch onto cancer antigens more strongly and specifically than those of established TCR T-cell therapy biotechs such as Immatics and Adaptimmune. We are letting the mice select the best TCR via a very natural in vivo selection mechanism which means they are less likely to have off-target reactivity, she said.

T-knife exited stealth mode with the Series A round, which was led by the investment firms Versant Ventures and RA Capital Management. The company has already initiated the clinical development of a myeloma treatment and plans to sponsor a solid tumor trial in late 2021.

One drawback of cell therapies based on genetically modifying the patients own T cells is that the process is complex, costly, and must be tailored to each patient. To get around this issue, several European startups have been developing TCR T-cell therapies that use donor immune cells in an off-the-shelf fashion, cutting the costs of the therapy.

One such company is the Norwegian startup Zelluna Immunotherapy, which raised 7.5M in equity funding and grants in June. The company aims to develop a TCR T-cell therapy based on cancer-hunting immune cells called natural killer cells. The company sees these cells as well suited for making off-the-shelf therapies since they have a lower risk of attacking the patients healthy tissue than T cells and are faster at killing cancer cells.

Another off-the-shelf TCR T-cell therapy in the works is being developed by the Dutch biotech Gadeta, which appointed a new CEO in April. It is working with the US company Kite Pharma to engineer T cells that produce TCRs from a rare type of T cell called gamma delta T cells. The TCRs from gamma delta T cells are better at recognizing stress signals on cancer cells than those of the more common type of T cells, called alpha beta T cells.

Gadetas platform combines the key features ofalpha beta T cells, such as the high proliferation and memory capacity, with the anti-tumor specificity and activity of selectedgamma delta receptors, Marco Londei, the companys new CEO, told me. This novel T cell platform is perfectly placed for possible allogeneic off-the-shelf use.

Gadeta is currently preparing to enter phase I testing for the treatment of multiple myeloma.

TC Biopharm has also hinted at promising progress with its own off-the-shelf cancer cell immunotherapy. The Scottish startup collects gamma delta T cells from young, healthy donors and makes them produce CAR proteins like a CAR T-cell therapy.

In some patients, the innate ability to hunt and kill cells is compromised either because of the cancer itself, other pathologies or age, Michael Leek, CEO of TC BioPharm, explained.

This is no ordinary CAR T-cell therapy, however. TC BioPharm also uses the gamma delta T cells TCRs as a safety catch to avoid destroying healthy cells that happen to show a cancer target. The CAR protein recognizes a cancer target on the cell surface, but the gamma delta TCR only allows the cell therapy to kill cells that show signs of stress from cancer. This could make it much safer than current CAR T-cell therapies.

TC BioPharm initiated a phase I clinical trial for the treatment of the blood cancer acute myeloid leukemia last year. The trial has progressed well; all qualifying patients saw a marked response to treatment with reduction of their tumor burden, Leek told me. We hope to progress this therapy to market around 2021-22.

In addition to cancer, TC BioPharm has also joined a growing list of immuno-oncology companies testing the potential of its technology for the treatment of Covid-19, launching a phase I trial in July.

Though TCR T-cell therapies can target more types of cancer than CAR T-cell therapies, they still tend to be specific to particular types of cancers, and ineffective against others. One cancer entity is oftentimes much more heterogeneous than initially thought, Kai Pinkernell, CMO of Munich-based Medigene, told me. Could such a therapy target more than one cancer type?

In June, Medigene initiated a phase I clinical trial of a TCR T-cell therapy candidate for a diverse range of blood cancers. The treatment is designed to hit a target that they all have in common called HA-1. The trial is testing the treatment in patients that recently received a bone marrow stem cell transplant, but whose blood cancer has relapsed.

[Our therapy] would improve the current gold-standard approach, being stem cell transplantation. Interestingly, this could work in many different diseases that were the reason for the transplant, Pinkernell explained.

Another TCR T-cell therapy player aims to go even further with widening the range of treatments. In January, the London-based Ervaxx recently rebranded as Enara Bio entered a partnership agreement with the University of Cardiff to overcome a common limitation of TCR therapies: the HLA molecules that TCRs scan vary widely between patients, so TCR T-cell therapies need to be personalized to different patients.

To get around this obstacle, Enara Bio and a research group led by Andrew Sewell, Professor of Immunology at Cardiff University, are developing a type of TCR T-cell therapy that doesnt scan HLA, but rather a protein called MR1, which is the same from patient to patient and is found on a wide range of cancer cells.

We have various T-cell receptors that respond to most cancers without the need for a specific human leukocyte antigen that we are exploring, Sewell told me.

By accessing a wide range of cancers and patients, this cancer immunotherapy could work universally with no need for personalization. The team aims to test the therapy in humans at the end of this year.

While a universal cancer therapy is an intriguing concept, Pinkernell thinks that we should be cautious in our expectations of seeing such a therapy. The timing of the drug in the therapy of a cancer, or best window of application is not easy to find, he said.

T-knifes Kieback echoed the skepticism. For now, rather highly tumor-, target-, and patient-specific therapies will be required and emerge, she said. Londei of Gadeta agreed and pointed out the complexity of cancer disease development. Key challenges are understanding how tumors escape immunotherapies and how to find combination therapies to overcome this problem, for different types of tumors, he added.

Sewell has a slightly more optimistic take. I think it is a bit strong to say that there is potential for universal therapies, but we can definitely build T cells that recognize most cancers from all individuals. I feel that there is a prospect for immunotherapy to be successfully treating most cancers within the next 25 years.

Part of the reason for the unclear potential of TCR T-cell therapy is that it is at an early stage in the clinical pipeline. The most advanced TCR T-cell therapy programs havent yet gone beyond phase II, such as that of Adaptimmunes lead candidate. However, the size of T-knifes recent Series A round demonstrates that investors are interested in the future of the technology, so its going to be worth keeping an eye on the TCR T-cell startup scene in the coming years.

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How European Startups Have Advanced Cancer T-Cell Therapy in... - Labiotech.eu

Bone Marrow Stem Cells Comments Off on How European Startups Have Advanced Cancer T-Cell Therapy in… – Labiotech.eu | August 11th, 2020

Stem Cell Therapy Market is expected to reach 202.77 billion by 2026 from XX billion in 2018 at CAGR of XX %.REQUEST FOR FREE SAMPLE REPORT:https://www.maximizemarketresearch.com/request-sample/522

Stands for use of stem cells to treat or prevent disease or condition.Bone marrow transplant and some therapies derived from umbilical cord blood are mainly used in stem cell therapy. Advancement, in order to establish new sources for stem cells, and to apply stem-cell treatments for neurodegenerative diseases and conditions such as diabetes, heart disease, and other conditions, are increased in recent years.

The report study has analyzed revenue impact of covid-19 pandemic on the sales revenue of market leaders, market followers and disrupters in the report and same is reflected in our analysis.

Stem Cell Therapy Market Researchers are making efforts to discover novel methods to create human stem cells. This will increase the demand as well as supply for stem cell production and potential investigation in disease management. Increasing investment & research grants for developing safe and effective stem cell therapy products, the growing patient base for target diseases, concentrated product pipelines, increasing approval of the new clinical trials, rapid technological advancement in genomics, and the rising awareness about the stem cell are expected to drive the growth of the Stem Cell Therapy solutions market during the forecast period.

However, improper infrastructure, insufficient storage systems, nascent technology in underdeveloped economies, Ethical issues related to an embryonic stem cell, low patient acceptance rate, Difficulty in the preservation of stem cell are expected to restrain the market growth. North America is expected to be the largest growing region by 2026; the reason behind that is extensive funding by Government. However, Emerging countries like India, china, Korea have low growth rate as compared to Developed regions in 2017 but increase in awareness about stem cell therapy will lead the Asia Pacific to generate a significant level of revenue by 2026.

Key Highlights of Stem Cell Therapy Market report

Detailed quantitative analysis of the current and future trends from 2017 to 2026, which helps to identify the prevailing market opportunities.Comprehensive analysis of factors instrumental in changing the market scenario, rising prospective opportunities, market shares, core competencies in terms of market development, growth strategies and identification of key companies that can influence this market on a global and regional scale.Assessment of Market definition along with the identification of key drivers, restraints opportunities and challenges for this market during the forecast period.Complete analysis of micro-markets with respect to individual growth trends, prospects, and contributions to the overall Stem Cell Therapy Solutions market.Stem Cell Therapy market analysis and comprehensive segmentation with respect to the Application, End users, Treatment, and geography to assist in strategic business planning.Stem Cell Therapy market analysis and forecast for five major geographies-North America, Europe, Asia Pacific, Middle East & Africa, Latin America, and their key regions.For company profiles, 2017 has been considered as the base year. In cases, wherein information was unavailable for the base year, the years prior to it have been considered.

Research Methodology:

The market is estimated by triangulation of data points obtained from various sources and feeding them into a simulation model created individually for each market. The data points are obtained from paid and unpaid sources along with paid primary interviews with key opinion leaders (KOLs) in the market. KOLs from both, demand and supply side were considered while conducting interviews to get an unbiased idea of the market. This exercise was done at a country level to get a fair idea of the market in countries considered for this study. Later this country-specific data was accumulated to come up with regional numbers and then arrive at a global market value for the stem cell therapy market.Key Players in the Stem Cell Therapy Market are:

Chiesi Farmaceutici S.P.A Are:Gamida CellReNeuron Group, plcOsiris Therapeutics, Inc.Stem Cells, Inc.Vericel Corporation.Mesoblast, Ltd.

Key Target Audience:

Stem Cell Associations and OrganizationsGovernment Research Boards and OrganizationsResearch and consulting firmsStem Cell Therapy Market InvestorsHealthcare Service Providers (including Hospitals and Diagnostic Centers)Stem Cell Therapeutic Product Manufacturing OrganizationsResearch LabsClinical research organizations (CROs)Stem Cell Therapy Marketing PlayersPharmaceutical Product Manufacturing CompaniesScope of the Stem Cell Therapy Market Report:

Stem Cell Therapy market research report categorizes the Stem Cell Therapy market based on Application, End users, Treatment, and geography (region wise). Market size by value is estimated and forecasted with the revenues of leading companies operating in the Stem Cell Therapy market with key developments in companies and market trends.Stem Cell Therapy Market, By Treatments:

Allogeneic Stem Cell TherapyAutologous Stem Cell Therapy

Stem Cell Therapy Market, By End Users:

HospitalsAmbulatory Surgical Centers

Stem Cell Therapy Market, By Application:

OncologyCentral Nervous System DiseasesEye DiseasesMusculoskeletal DiseasesWound & InjuriesMetabolic DisordersCardiovascular DisordersImmune System DisordersStem Cell Therapy Market, By Geography:

North AmericaEuropeAsia PacificMiddle East & AfricaLatin America

Available Customization:

With the given market data, Maximize Market Research offers customization of report and scope of the report as per the requirement

Regional Analysis:

Breakdown of the North America stem cell therapy marketBreakdown of the Europe stem cell therapy marketBreakdown of the Asia Pacific stem cell therapy marketBreakdown of the Middle East & Africa stem cell therapy marketBreakdown of the Latin America stem cell therapy market

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Stem Cell Therapy Market by Treatment,Application,End Users and Geography Forecast To 2026 - Good Night, Good Hockey

Bone Marrow Stem Cells Comments Off on Stem Cell Therapy Market by Treatment,Application,End Users and Geography Forecast To 2026 – Good Night, Good Hockey | August 11th, 2020

Latest released the research study on Global Orthopedic Regenerative Medicine Market, offers a detailed overview of the factors influencing the global business scope. Orthopedic Regenerative Medicine Market research report shows the latest market insights, current situation analysis with upcoming trends and breakdown of the products and services. The report provides key statistics on the market status, size, share, growth factors of the Orthopedic Regenerative Medicine. The study covers emerging players data, including: competitive landscape, sales, revenue and global market share of top manufacturers are Curasan, Inc., Carmell Therapeutics Corporation, Anika Therapeutics, Inc., Conatus Pharmaceuticals Inc., Histogen Inc., Royal Biologics, Ortho Regenerative Technologies, Inc., Swiss Biomed Orthopaedics AG, Osiris Therapeutics, Inc., and Octane Medical Inc.

Definition:

Orthopedic Regenerative Medicine strategy sends messages to the customers or subscribers in predefined schedule. However, other forms of media can also be used in Orthopedic Regenerative Medicine. It is the most common form of marketing as multiple messages can be sent in low costs. Orthopedic Regenerative Medicine is used to achieve business objectives such as increasing sales, maintaining communications with customers while saving the business time. Moreover, the users can personalize each of the email messages and increase conversion rate.

Market Drivers

Market Trend

Opportunities

Challenges

Detailed Segmentation:

By Procedure Cell TherapyTissue EngineeringBy Cell TypeInduced Pluripotent Stem Cells (iPSCs)Adult Stem CellsTissue Specific Progenitor Stem Cells (TSPSCs),Mesenchymal Stem Cells (MSCs)Umbilical Cord Stem Cells (UCSCs)Bone Marrow Stem Cells (BMSCs)By SourceBone MarrowUmbilical Cord BloodAdipose TissueAllograftsAmniotic FluidBy ApplicationsTendons RepairCartilage RepairBone RepairLigament RepairSpine RepairOthers

Analyst at CMI have conducted special survey and have connected with opinion leaders and Industry experts from various region to minutely understand impact on growth as well as local reforms to fight the situation. A special chapter in the study presents Impact Analysis of COVID-19 on Global Orthopedic Regenerative Medicine Market along with tables and graphs related to various country and segments showcasing impact on growth trends.

o North America (United States, Canada, and Mexico)

o Europe (Germany, France, UK, Russia, and Italy)

o Asia-Pacific (China, Japan, Korea, India, and Southeast Asia)

o South America (Brazil, Argentina, Colombia)

o Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria, and South Africa)

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Strategic Points Covered in Table of Content of Global Orthopedic Regenerative Medicine Market:

Chapter 1: Introduction, market driving force product Objective of Study and Research Scope the Orthopedic Regenerative Medicine market

Chapter 2: Exclusive Summary the basic information of the Orthopedic Regenerative Medicine Market.

Chapter 3: Displaying the Market Dynamics- Drivers, Trends and Challenges of the Orthopedic Regenerative Medicine

Chapter 4: Presenting the Orthopedic Regenerative Medicine Market Factor Analysis Porters Five Forces, Supply/Value Chain, PESTEL analysis, Market Entropy, Patent/Trademark Analysis.

Chapter 5: Displaying market size by Type, End User and Region 2014-2019

Chapter 6: Evaluating the leading manufacturers of the Orthopedic Regenerative Medicine market which consists of its Competitive Landscape, Peer Group Analysis

Chapter 7: To evaluate the market by segments, by countries and by manufacturers with revenue share and sales by key countries (2019-2027).

Chapter 8 & 9: Displaying the Appendix, Methodology and Data Source

Finally, Orthopedic Regenerative Medicine Market is a valuable source of guidance for individuals and companies in decision framework.

Data Sources & Methodology

The primary sources involves the industry experts from the Global Orthopedic Regenerative Medicine Market including the management organizations, processing organizations, analytics service providers of the industrys value chain. All primary sources were interviewed to gather and authenticate qualitative & quantitative information and determine the future prospects.

In the extensive primary research process undertaken for this study, the primary sources Postal Surveys, telephone, Online & Face-to-Face Survey were considered to obtain and verify both qualitative and quantitative aspects of this research study. When it comes to secondary sources Companys Annual reports, press Releases, Websites, Investor Presentation, Conference Call transcripts, Webinar, Journals, Regulators, National Customs and Industry Associations were given primary weight-age.

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What benefits does CMI research study is going to provide?

Definitively, this report will give you an unmistakable perspective on every single reality of the market without a need to allude to some other research report or an information source. Our report will give all of you the realities about the past, present, and eventual fate of the concerned Market.

Thanks for reading this article; you can also get individual chapter wise section or region wise report version like North America, Europe or Southeast Asia.

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Coherent Market Insights is a global market intelligence and consulting organization focused on assisting our plethora of clients achieve transformational growth by helping them make critical business decisions. We are headquartered in India, having office at global financial capital in the U.S. Our client base includes players from across all business verticals in over 150 countries worldwide. We are uniquely positioned to help businesses around the globe deliver practical and lasting results through various recommendations about operational improvements, technologies, emerging market trends and new working methods.

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Covid-19 Impact on Global Orthopedic Regenerative Medicine Market Rapid Growth By 2019 2027 | Curasan, Inc., Carmell Therapeutics Corporation, Anika...

Bone Marrow Stem Cells Comments Off on Covid-19 Impact on Global Orthopedic Regenerative Medicine Market Rapid Growth By 2019 2027 | Curasan, Inc., Carmell Therapeutics Corporation, Anika… | August 11th, 2020

METUCHEN, N.J., Aug. 10, 2020 /PRNewswire/ --Tevogen Bio announces a joint partnership with renowned bone-marrow transplant expertNeal Flomenberg, M.D., Professor and Chair of the Department of Medical Oncology at Thomas Jefferson University, with the intent to evaluate Tevogen' s proprietary antigen-specific T cell technology as a potential treatment for COVID-19 and influenza-A patients.

This collaboration aims to harness Tevogen's proprietary immunotherapy platform and Dr. Flomenberg's expertise and research prowess to investigate potential treatments for viral infections.

Dr. Flomenberg has been at the forefront of immunogenetics and immunology for more than four decades. "Tevogen's technology resonated with me as there have been several groups who have used T cells to treat patients after bone-marrow transplants. The idea of utilizing T cell therapies to potentially treat COVID-19 and other viruses is truly remarkable," Flomenberg said. "I'm enthusiastic about moving forward with an investigation of Tevogen's technologies."

Tevogen CEO Ryan Saadi, M.D., M.P.H., is leading the new biotech's efforts. "Our work has been to pioneer T cell therapies that can be abundantly and efficiently reproduced to develop an affordable and scalable cellular treatment for the biggest global health threats, including COVID-19, influenza, and a variety of cancers. We are very excited about Dr. Flomenberg's contribution to our efforts and hope to initiate our investigational study soon."

In addition to developing its potential therapies, Tevogen is committed to organizational and manufacturing efficiency. This should allow it to engage in affordable innovation to the benefit of all patients.

About Tevogen Bio

Tevogen Bio was formed after decades of research by its contributors to concentrate and leverage their expertise, spanning multiple sectors of the health care industry, to help address some of the most common and deadly illnesses known today. The company's mission is to provide curative and preventative treatments that are affordable and scalablein order to positively impact global public health.

About Dr. Neal Flomenberg

Dr. Neal Flomenberg is the Chairman of Medical Oncology at Jefferson University in Philadelphia and also heads the Hematologic Malignancies, Blood and Marrow Transplantation (BMT) Program. Throughout his more than four decades of practice, he has maintained a longstanding interest in the immunogenetics and immunology of stem cell transplantation, with the goal of making transplantation safer and more widely available. Dr. Flomenberg developed an approach to bone-marrow transplants that uses half-matched relatives as donors, a breakthrough that assures that the majority of blood and bone-marrow cancer patients can benefit from this potentially curative treatment.

Media Contacts:

Mark Irion[emailprotected]

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Tevogen Bio Announces Partnership With Preeminent Scientist Professor Neal Flomenberg, MD, to Investigate Proprietary T-Cell Therapy for Treatment of...

Bone Marrow Stem Cells Comments Off on Tevogen Bio Announces Partnership With Preeminent Scientist Professor Neal Flomenberg, MD, to Investigate Proprietary T-Cell Therapy for Treatment of… | August 10th, 2020

His name means brave in Hindi. And for four year-old Veer Gudhka that couldnt be more appropriate.

For while the bubbly little boy might look fighting fit, he actually has just months to live.

Veer suffers from a rare blood disorder called Fanconi anaemia, which results in a decreased production of all types of blood cells.

But a stem cell donor will save his life.

In a heartfelt video message, the plucky toddler asks Sunday Mirror readers: Please be my life-saver? Will you be my superhero?

And today his family are appealing to those from BAME communities to help by signing up to the Anthony Nolan stem cell register.

Mum Kirpa and dad Nirav know the odds are stacked against them getting that all-important call because they are of Indian descent.

While 69 per cent of Northern European patients find the best possible stem cell match from a stranger, this drops to just 20 per cent for those with black, Asian or ethnic minority backgrounds.

Currently only two per cent of the population is on the UK stem cell register.

And with Asians making up just six per cent of the UK population, there is a smaller pool of potential donors.

Veer was diagnosed with the blood disorder last August, after he started suffering from extreme fatigue, and was referred for tests.

Doctors said he would need a stem cell transplant within three years for a chance of survival.

They hoped to buy Veer some time by putting him on steroids to boost his blood counts. But his condition has deteriorated fast.

Recent tests at Great Ormond Street Hospital in London show he now has just three to four months to find a donor.

Kirpa and Nirav were both tested, along with Veers six-year-old sister Suhani, but none of them were a match.

A search on the global stem cell register also drew a blank.

And his dad has been trying to encourage his fellow countrymen and women in India to join the register.

They have even signed up a female battalion of the Indian Army.

Kirpa, 37, from Harrow, London, said: We just feel so scared were going to lose our cheeky, amazing little boy. To look at Veer you wouldnt know hes critically ill.

Like his name, hes been brave from the start. Hes undergone countless tests and hospital visits but has had a constant smile on his face.

"He knows he needs a superhero to step forward, but his optimism and enthusiasm are infectious and keep us all going.

She added: Going on the register is incredibly quick and donating cells if you match someone in need is painless.

You can join the Anthony Nolan stem cell register today.

Nine out of 10 people donate their stem cells through the bloodstream in a simple IV process called peripheral blood stem cell collection.

One in 10 will have their stem cells collected via the bone marrow itself, while under general anaesthetic. Doctors transplant the new, healthy cells via the patients bloodstream, where they begin to grow and create healthy red blood cells, white blood cells and platelets.

A perfect match from a donor can mean a lifelong cure.

Veers dad Nirav, 40, said: I only learned about the Anthony Nolan stem cell register two years ago and even then I assumed it would involve long and painful procedures.

We need to raise awareness to save lives in every community.

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Boy, 4, may look fighting fit but only has months to live - unless you can save him - Mirror Online

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Global Cell Therapy Technologies Marketwas valued US$ 12 billion in 2018 and is expected to reach US$ 35 billion by 2026, at CAGR of 12.14 %during forecast period.

The objective of the report is to present comprehensive assessment projections with a suitable set of assumptions and methodology. The report helps in understanding Global Cell Therapy Technologies Market dynamics, structure by identifying and analyzing the market segments and projecting the global market size. Further, the report also focuses on the competitive analysis of key players by product, price, financial position, growth strategies, and regional presence. To understand the market dynamics and by region, the report has covered the PEST analysis by region and key economies across the globe, which are supposed to have an impact on market in forecast period. PORTERs analysis, and SVOR analysis of the market as well as detailed SWOT analysis of key players has been done to analyze their strategies. The report will to address all questions of shareholders to prioritize the efforts and investment in the near future to the emerging segment in the Global Cell Therapy Technologies Market.

The report study has analyzed revenue impact of covid-19 pandemic on the sales revenue of market leaders, market followers and disrupters in the report and same is reflected in our analysis.

Global Cell Therapy Technologies Market: Overview

Cell therapy is a transplantation of live human cells to replace or repair damaged tissue and/or cells. With the help of new technologies, limitless imagination, and innovative products, many different types of cells may be used as part of a therapy or treatment for different types of diseases and conditions. Celltherapy technologies plays key role in the practice of medicine such as old fashioned bone marrow transplants is replaced by Hematopoietic stem cell transplantation, capacity of cells in drug discovery. Cell therapy overlap with different therapies like, gene therapy, tissue engineering, cancer vaccines, regenerative medicine, and drug delivery. Establishment of cell banking facilities and production, storage, and characterization of cells are increasing volumetric capabilities of the cell therapy market globally. Initiation of constructive guidelines for cell therapy manufacturing and proven effectiveness of products, these are primary growth stimulants of the market.

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Global Cell Therapy Technologies Market: Drivers and Restraints

The growth of cell therapy technologies market is highly driven by, increasing demand for clinical trials on oncology-oriented cell-based therapy, demand for advanced cell therapy instruments is increasing, owing to its affordability and sustainability, government and private organization , investing more funds in cell-based research therapy for life-style diseases such as diabetes, decrease in prices of stem cell therapies are leading to increased tendency of buyers towards cell therapy, existing companies are collaborating with research institute in order to best fit into regulatory model for cell therapies.Moreover, Healthcare practitioners uses stem cells obtained from bone marrow or blood for treatment of patients with cancer, blood disorders, and immune-related disorders and Development in cell banking facilities and resultant expansion of production, storage, and characterization of cells, these factors will drive the market of cell therapy technologies during forecast period.

On the other hand, the high cost of cell-based research and some ethical issue & legally controversial, are expected to hamper market growth of Cell Therapy Technologies during the forecast period

AJune 2016, there were around 351 companies across the U.S. that were engaged in advertising unauthorized stem cell treatments at their clinics. Such clinics boosted the revenue in this market.in August 2017, the U.S. FDA announced increased enforcement of regulations and oversight of clinics involved in practicing unapproved stem cell therapies. This might hamper the revenue generation during the forecast period; nevertheless, it will allow safe and effective use of stem cell therapies.

Global Cell Therapy Technologies Market: Segmentation Analysis

On the basis of product, the consumables segment had largest market share in 2018 and is expected to drive the cell therapy instruments market during forecast period at XX % CAGR owing to the huge demand for consumables in cell-based experiments and cancer research and increasing number of new product launches and consumables are essential for every step of cell processing. This is further expected to drive their adoption in the market. These factors will boost the market of Cell Therapy Technologies Market in upcoming years.

On the basis of process, the cell processing had largest market share in 2018 and is expected to grow at the highest CAGR during the forecast period owing to in cell processing stage,a use of cell therapy instruments and media at highest rate, mainly in culture media processing. This is a major factor will drive the market share during forecast period.

Global Cell Therapy Technologies Market: Regional Analysis

North America to held largest market share of the cell therapy technologies in 2018 and expected to grow at highest CAGR during forecast period owing to increasing R&D programs in the pharmaceutical and biotechnology industries. North America followed by Europe, Asia Pacific and Rest of the world (Row).

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Scope of Global Cell Therapy Technologies Market

Global Cell Therapy Technologies Market, by Product

Consumables Equipment Systems & SoftwareGlobal Cell Therapy Technologies Market, by Cell Type

Human Cells Animal CellsGlobal Cell Therapy Technologies Market, by Process Stages

Cell Processing Cell Preservation, Distribution, and Handling Process Monitoring and Quality ControlGlobal Cell Therapy Technologies Market, by End Users

Life Science Research Companies Research InstitutesGlobal Cell Therapy Technologies Market, by Region

North America Europe Asia Pacific Middle East & Africa South AmericaKey players operating in the Global Cell Therapy Technologies Market

Beckman Coulter, Inc. Becton Dickinson and Company GE Healthcare Lonza Merck KGaA MiltenyiBiotec STEMCELL Technologies, Inc. Terumo BCT, Inc. Thermo Fisher Scientific, Inc. Sartorius AG

MAJOR TOC OF THE REPORT

Chapter One: Cell Therapy Technologies Market Overview

Chapter Two: Manufacturers Profiles

Chapter Three: Global Cell Therapy Technologies Market Competition, by Players

Chapter Four: Global Cell Therapy Technologies Market Size by Regions

Chapter Five: North America Cell Therapy Technologies Revenue by Countries

Chapter Six: Europe Cell Therapy Technologies Revenue by Countries

Chapter Seven: Asia-Pacific Cell Therapy Technologies Revenue by Countries

Chapter Eight: South America Cell Therapy Technologies Revenue by Countries

Chapter Nine: Middle East and Africa Revenue Cell Therapy Technologies by Countries

Chapter Ten: Global Cell Therapy Technologies Market Segment by Type

Chapter Eleven: Global Cell Therapy Technologies Market Segment by Application

Chapter Twelve: Global Cell Therapy Technologies Market Size Forecast (2019-2026)

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Global Cell Therapy Technologies Market : Industry Analysis and Forecast (2019-2026) by Product, Technique, End Users and Region. - Good Night, Good...

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New Delhi: Human immunity and its components have never been the topic of such breathless discussion for such a long time. But then, there has never been a time like the Covid-19 pandemic.

Between serological surveys (that check the level of antibodies against the SARS-CoV-2 virus in blood), rapid antigen tests (that test for the part of the virus that kickstarts immune mechanisms) and the quest for vaccines, the immune system is very much in.

That is also why lymphocytes (a class of white blood cells), especially the ones known as T-cells are the flavour of the season. They are probably the single most important component of the immune system; though given the perfectly synchronised working of the defence mechanism of the body, it may be a little unfair to designate any one as more important than the another.

T-cells play a plethora of roles in immunity as killer cells that can attack an infected cell and kill it along with the infecting agent, and as suppressor cells that modulate the level of functioning of other lymphocytes. They also have a starring role in the production of antibodies, a function performed by the other variant of lymphocytes called the B cells.

Latest research in Nature shows that presence of T-cells from earlier encounters with coronaviruses could have an important role to play in the bodys immune response, and therefore, a better understanding of it is crucial for the development of a vaccine.

The published data discussed here indicate that patients with severe COVID-19 can have either insufficient or excessive T cell responses. It is possible, therefore, that disease might occur in different patients at either end of this immune response spectrum, in one case from virus-mediated pathology and in the other case from T cell-driven immunopathology.

However, it is unclear why some patients respond too little and some patients too much, and whether the strength of the T cell response in the peripheral blood reflects the T cell response intensity in the respiratory tract and other SARS-CoV-2-infected organs, wrote the researchers from the University of Pennsylvania. They called for more research on the topic.

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Turns out, antibodies may or may not last, but T-cells are the new superheroes with the potential to possibly save the planet.

Also read: T Cells the unsung immune warriors that takeover after coronavirus antibodies wane

Immunity is of two kinds innate and acquired.

The defence mechanisms that the body is born with is known an innate immunity. This includes something as simple as the ability of the skin to prevent inner, more vulnerable tissues, from coming in contact with the external environment.

Acquired immunity, as the name suggests, is something that develops over time through exposure to pathogens or disease causing agents like virus and bacteria. Acquired immunity kicks in either through antibodies (this is known as humoral immunity) or through cells programmed to destroy invading organisms by causing the dissolution of the very cells that have been infected.

White blood cells (WBC) play a crucial role in immunity. There are five different kinds of WBCs eosinophil, basophil, neutrophil, monocyte and lymphocyte. Among these, the most important are lymphocytes, which include the T lymphocytes and the B lymphocytes. However, the others also have important roles to play as supporting cast. For the present discussion, we are concentrating on lymphocytes.

Also read: Immunity boosters are a myth why you shouldnt believe claims that promise to fight Covid

Structurally, under a microscope, very little differentiates a T-lymphocyte from a B lymphocyte. Both varieties are formed in the bone marrow from stem cells, get trained in different organs and then lodge themselves in the lymph nodes from where they are deployed when the occasion arises.

The training is important. It teaches the cells not to start attacking the bodys own cells. T-cells get trained antenatally (during pregnancy) and for some time after that in the thymus, a small gland present between the lungs only till puberty. B cells are trained in the foetal liver and bone marrow.

When a pathogen invades, specific chemicals unique to it (often proteins or complex carbohydrates) activate the bodys immune system. This activator, which is a unique feature of the invading pathogen, is the antigen. This is what the rapid antigen test looks for.

When an antigen has been detected, the T-cells troop out of the lymph node in an activated form and travel to the affected areas to take on the infection. The activated cells, called the Killer T cells, attach themselves to the membrane of the infected cell and with help of cytotoxic chemicals, kill the cell and destroy the invader with it. This is cell-mediated immunity. It is the basis of what happens when transplanted organs are rejected.

The thymus training teaches T-cells to ignore the antigens that are present within the body and not attack them. When that lesson is forgotten, because of genetic or environmental reasons, an autoimmune disorder is triggered.

Antigens set in motion a different pathway in the B lymphocytes. These enlarge and start duplicating very rapidly to form many clones, all of which, on maturity, start producing antibodies. The whole process happens very fast.

Antibodies are protein molecules that are present in the plasma, the matrix of the blood in which the cells float. Not all T-cells though turn into cytotoxic killers. Some become what are known as helper T cells, to go and further activate B lymphocytes to produce antibodies. In fact, without these helper cells, the antibody output is not quite sufficient to combat the invading particle.

Antibodies can directly kill the invader using a number of different mechanisms at their disposal. They can also activate a set of proteins present in the blood plasma that in turn can attack the invader using their own pathways.

Once the infection has been tackled, some of the B lymphocytes are tucked away with information about how this was done. These are memory cells that remain dormant until the next invasion happens. These ensure that when an infection recurs, the response is expedited, magnified and is longer lasting. This is the principle behind vaccination to teach the body to identify and combat a pathogen so that when a future infection happens, the response is stronger.

Also read:An Oxford immunologist breaks down how the universitys vaccine works against Covid-19

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T cells, B cells and the range of the human bodys immune response A simple decoder - ThePrint

Bone Marrow Stem Cells Comments Off on T cells, B cells and the range of the human bodys immune response A simple decoder – ThePrint | August 10th, 2020

Global Multiple Myeloma Treatment Marketsize was valued US$ XX Mn. in 2019 and the total revenue is expected to grow at 11.34% from 2019 to 2027, reaching nearly US$ XX Mn.

The report study has analyzed the revenue impact of COVID -19 pandemic on the sales revenue of market leaders, market followers, and market disrupters in the report, and the same is reflected in our analysis.

Multiple myeloma, also known as Kahlers disease, is a type of blood cancer of plasma cells that are found in the bone marrow. Multiple myeloma causes cancer cells to accrue in the bone marrow, where they attack the strong blood cells.

Multiple myeloma treatments have developed significantly above the last decade. New multiple myeloma treatments have provided efficient survival rates between myeloma patients. It has been also observed that the future drug pipeline of multiple myeloma is promising, biological drugs and stem cell-based therapies are likely to fuel the multiple myeloma treatment market in the upcoming years. On the other hand, the costs of radiotherapeutic equipment implementation, a limited number of target patients population, strict legal regulations are expected to hamper the market growth. Likewise, the MMR report contains a detailed study of factors that will drive and restrain the growth of the multiple myeloma treatment market globally.

Multiple Myeloma accounts for approximately 2.5% of the cancer-related deaths globally and is the second most major type of blood cancer next to Hodgkins Lymphoma. According to the World Cancer Research Fund, in 2018, above 159500 cases of multiple myeloma were diagnosed with the condition, where the occurrence rate among women and men was found in the ratio 1.2:1. The onset of the disease occurs after the age of 60. In recent times, the age of onset is drastically decreasing. In the year 2001, only two medications were available for treating multiple myeloma but now in 2020, 18 medicines are available. Moreover, there are over 25 FDA-approved drugs for treating multiple myeloma with therapeutics such as pomalidomide, carfilzomib, panobinostat, and ixazomib. The availability of new medications has given new hope for better treatments and better results and thus affecting the growth of the market as well. However, the survival of patients with a limited response while receiving treatment with primary immunodeficiency therapy remains poor and is one of the major challenges.

The MMR report covers the segments in the multiple myeloma treatment market such as type and application. By application, the hospital is expected to continue to hold the largest XX.85% share in multiple myeloma treatments market thanks to growing specialist doctors providing the best chance of long term survival.

North Americas multiple myeloma treatments market was valued at US$ XX.26 Mn. in 2019 and is expected to reach a value of US$ XX.13 Mn. by 2027, with a CAGR of 9.3%. The number of patients in the U.S is growing YoY with nearly 14600 new cases diagnosed annually. In 2017 alone there were approximately 142000 patients diagnosed for multiple myeloma.

Europe and the South African population are prone to develop multiple myeloma when compared with Asian economies. Though, the population in the APAC region outwits Europe and Africa. Further, growing the adoption rate of novel therapies, coupled with the support from the government along with non-government organizations and improving the survival of multiple myeloma patients.

The research study includes the profiles of leading players operating in the global multiple myeloma treatment market. Eli Lilly Company acquired ARMO Biosciences to develop immunotherapies for the treatment of cancer, hypercholesterolemia, inflammatory, and fibrosis diseases.

The objective of the report is to present a comprehensive analysis of the Global Multiple Myeloma Treatment Market including all the stakeholders of the industry. The past and current status of the industry with forecasted market size and trends are presented in the report with the analysis of complicated data in simple language. The report covers all the aspects of the industry with a dedicated study of key players that includes market leaders, followers, and new entrants. PORTER, SVOR, PESTEL analysis with the potential impact of micro-economic factors of the market has been presented in the report. External as well as internal factors that are supposed to affect the business positively or negatively have been analyzed, which will give a clear futuristic view of the industry to the decision-makers.The report also helps in understanding Global Multiple Myeloma Treatment Market dynamics, structure by analyzing the market segments and projects the Global Multiple Myeloma Treatment Market size. Clear representation of competitive analysis of key players by Application, price, financial position, Product portfolio, growth strategies, and regional presence in the Global Multiple Myeloma Treatment Market make the report investors guide.Scope of the Global Multiple Myeloma Treatment Market

Global Multiple Myeloma Treatment Market, by Applications

Hospitals Clinics Cancer Treatment and Rehabilitation CentersGlobal Multiple Myeloma Treatment Market, by Type

Proteasome Inhibitors Immunomodulatory Agents (IMiDs) Histone Deacetylase (HDAC) Inhibitors Immunotherapy Cytotoxic ChemotherapyGlobal Multiple Myeloma Treatment Market, by Region

Asia Pacific North America Europe South America Middle East & AfricaKey players operating in Global Multiple Myeloma Treatment Market

Celgene Corporation Janssen Biotech, Inc. Bristol-Myers Squibb Company Novartis AG Cellectar Biosciences Inc. Millennium Pharmaceuticals Amgen, Inc. bbVie Genzyme Corporation Juno Therapeutics Eli Lilly and Company Glenmark Pharma

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Contact info:Name: Vikas GodageOrganization: MAXIMIZE MARKET RESEARCH PVT. LTD.Email: sales@maximizemarketresearch.comContact: +919607065656 / +919607195908Website:www.maximizemarketresearch.com

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Global Multiple Myeloma Treatment Market-Industry Analysis and forecast 2019 2027: By Application, Type, and Region. - Good Night, Good Hockey

Bone Marrow Stem Cells Comments Off on Global Multiple Myeloma Treatment Market-Industry Analysis and forecast 2019 2027: By Application, Type, and Region. – Good Night, Good Hockey | August 10th, 2020

Cell Therapy Industry Report focuses on Market Influence Factors, Growth Drivers, Restraints, Trends and Opportunities so that Market Players can face any challenges and take advantage of Lucrative Prospects available in the Global Cell Therapy market.

The Covid-19 (coronavirus) pandemic is impacting society and the overall economy across the world. The impact of this pandemic is growing day by day as well as affecting the supply chain. The COVID-19 crisis is creating uncertainty in the stock market, massive slowing of supply chain, falling business confidence, and increasing panic among the customer segments. The overall effect of the pandemic is impacting the production process of several industries including Medical Device, Pharmaceutical, Healthcare and many more. Trade barriers are further restraining the demand- supply outlook. As government of different regions have already announced total lockdown and temporarily shutdown of industries, the overall production process being adversely affected; thus, hinder the overall Cell Therapy Market globally. This report on Cell Therapy Market provides the analysis on impact on Covid-19 on various business segments and country markets. The report also showcase market trends and forecast to 2027, factoring the impact of Covid -19 Situation.

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The Emerging Players in the Cell Therapy Market includes Kolon TissueGene, Inc., MEDIPOST, JCR Pharmaceuticals Co. Ltd., Stemedica Cell Technologies, Inc., Osiris Therapeutics, Inc., NuVasive, Inc., Fibrocell Science, Inc., Vericel Corporation, Cells for Cells, Celgene Corporation, etc.

Cell Therapy Market Definitions and Overview:

Cell therapy (CT) is the process of transplanting human cells to replace or repair damaged tissue or cells. Various methods can be used to carry out cell therapy. For instance, hematopoietic stem cell transplantation, also known as bone marrow transplant, is the most widely used cell therapy. It is used to treat a variety of blood cancers and blood-related conditions.

Cell therapy market is expected to grow due to factors such as increasing the biotechnology industry, rising healthcare expenditure, growing incidences of chronic diseases, and others. The market is expected to have growth opportunities in the emerging region as they are developing their genetic sectors rapidly.

The research provides answers to the following key questions:

Competitive scenario:

The study assesses factors such as segmentation, description, and applications of Cell Therapy industries. It derives accurate insights to give a holistic view of the dynamic features of the business, including shares, profit generation, thereby directing focus on the critical aspects of the business.

Scope of the Report

The research on the Cell Therapy market focuses on mining out valuable data on investment pockets, growth opportunities, and major market vendors to help clients understand their competitors methodologies. The research also segments the Cell Therapy market on the basis of end user, product type, application, and demography for the forecast period 20212027. Comprehensive analysis of critical aspects such as impacting factors and competitive landscape are showcased with the help of vital resources, such as charts, tables, and infographics.

Cell Therapy Market Segmented by Region/Country: North America, Europe, Asia Pacific, Middle East & Africa, and Central & South America

Major highlights of the report:

All-inclusive evaluation of the parent market

Evolution of significant market aspects

Industry-wide investigation of market segments

Assessment of market value and volume in past, present, and forecast years

Evaluation of market share

Study of niche industrial sectors

Tactical approaches of market leaders

Lucrative strategies to help companies strengthen their position in the market

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Thanks for reading this article; you can also customize this report to get select chapters or region-wise coverage with regions such as Asia, North America, and Europe.

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Cell Therapy Market: Study Navigating the Future Growth Outlook | Osiris Therapeutics, NuVasive, Vericel Corporation - Chelanpress

Bone Marrow Stem Cells Comments Off on Cell Therapy Market: Study Navigating the Future Growth Outlook | Osiris Therapeutics, NuVasive, Vericel Corporation – Chelanpress | August 10th, 2020

Overview

We are a clinical stage biopharmaceutical company focused on the discovery,development and commercialization of drugs for the treatment of cancer. We aredeveloping proprietary drugs independently and through research and developmentcollaborations. Our core objective is to leverage our proprietary phospholipiddrug conjugate (PDC) delivery platform to develop PDCs that are designed tospecifically target cancer cells and deliver improved efficacy and better safetyas a result of fewer off-target effects. Our PDC platform possesses thepotential for the discovery and development of the next generation ofcancer-targeting treatments, and we plan to develop PDCs both independently andthrough research and development collaborations. The COVID-19 pandemic hascreated uncertainties in the expected timelines for clinical stagebiopharmaceutical companies such as us, and because of such uncertainties, it isdifficult for us to accurately predict expected outcomes at this time. We havenot yet experienced any significant impacts as a result of the pandemic and havecontinued to enroll patients in our clinical trials. However, COVID-19 mayimpact our future ability to recruit patients for clinical trials, obtainadequate supply of CLR 131 and obtain additional financing.

Our lead PDC therapeutic, CLR 131 is a small-molecule PDC designed to providetargeted delivery of iodine-131 directly to cancer cells, while limitingexposure to healthy cells. We believe this profile differentiates CLR 131 frommany traditional on-market treatment options. CLR 131 is the company's leadproduct candidate and is currently being evaluated in a Phase 2 study inrelapsed/refractory (r/r) B-cell malignancies, including multiple myeloma (MM),chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL),lymphoplasmacytic lymphoma/Waldenstrom's macroglobulinemia (LPL/WM), marginalzone lymphoma (MZL), mantle cell lymphoma (MCL), and diffuse large B-celllymphoma (DLBCL).CLR 131 is also being evaluated in a Phase 1 dose escalationstudy in pediatric solid tumors and lymphoma. The U.S. Food and DrugAdministration ("FDA") granted CLR 131 Fast Track Designation for both r/r MMand r/r DLBCL and Orphan Drug Designation (ODD) of MM, LPL/WM, neuroblastoma,rhabdomyosarcoma, Ewing's sarcoma and osteosarcoma. CLR 131 was also grantedRare Pediatric Disease Designation (RPDD) for the treatment of neuroblastoma,rhabdomyosarcoma, Ewing's sarcoma and osteosarcoma. Most recently, the EuropeanCommission granted an ODD for r/r MM.

Our product pipeline also includes one preclinical PDC chemotherapeutic program(CLR 1900) and several partnered PDC assets. The CLR 1900 Series is beingtargeted for solid tumors with a payload that inhibits mitosis (cell division) avalidated pathway for treating cancers.

We have leveraged our PDC platform to establish four collaborations featuringfive unique payloads and mechanisms of action. Through research and developmentcollaborations, our strategy is to generate near-term capital, supplementinternal resources, gain access to novel molecules or payloads, accelerateproduct candidate development and broaden our proprietary and partnered productpipelines.

Our PDC platform provides selective delivery of a diverse range of oncologicpayloads to cancerous cells, whether a hematologic cancer or solid tumor, aprimary tumor, or a metastatic tumor and cancer stem cells. The PDC platform'smechanism of entry does not rely upon specific cell surface epitopes or antigensas are required by other targeted delivery platforms. Our PDC platform takesadvantage of a metabolic pathway utilized by all tumor cell types in all stagesof the tumor cycle. Tumor cells modify specific regions on the cell surface as aresult of the utilization of this metabolic pathway. Our PDCs bind to theseregions and directly enter the intracellular compartment. This mechanism allowsthe PDC molecules to accumulate over time, which enhances drug efficacy, and toavoid the specialized highly acidic cellular compartment known as lysosomes,which allows a PDC to deliver molecules that previously could not be delivered.Additionally, molecules targeting specific cell surface epitopes face challengesin completely eliminating a tumor because the targeted antigens are limited inthe total number on the cell surface, have longer cycling time frominternalization to being present on the cell surface again and available forbinding and are not present on all of the tumor cells in any cancer. This meansa subpopulation of tumor cells always exist that cannot be targeted by therapiestargeting specific surface epitopes. In addition to the benefits provided by themechanism of entry, PDCs offer the ability to conjugate payload molecules innumerous ways, thereby increasing the types of molecules selectively deliveredvia the PDC.

The PDC platform features include the capacity to link with almost any molecule,provide a significant increase in targeted oncologic payload delivery and theability to target all types of tumor cells. As a result, we believe that we cangenerate PDCs to treat a broad range of cancers with the potential to improvethe therapeutic index of oncologic drug payloads, enhance or maintain efficacywhile also reducing adverse events by minimizing drug delivery to healthy cells,and increasing delivery to cancerous cells and cancer stem cells.

We employ a drug discovery and development approach that allows us toefficiently design, research and advance drug candidates. Our iterative processallows us to rapidly and systematically produce multiple generations ofincrementally improved targeted drug candidates.

In June 2020, the European Medicines Agency (EMA) granted us Small andMedium-Sized Enterprise status by the EMA's Micro, Small and Medium-sizedEnterprise office. SME status allows us to participate in significant financialincentives that include a 90% to 100% EMA fee reduction for scientific advice,clinical study protocol design, endpoints and statistical considerations,quality inspections of facilities and fee waivers for selective EMA pre andpost-authorization regulatory filings, including orphan drug and PRIMEdesignations. We are also eligible to obtain EMA certification of quality andmanufacturing data prior to review of clinical data. Other financial incentivesinclude EMA-provided translational services of all regulatory documents requiredfor market authorization, further reducing the financial burden of the marketauthorization process.

A description of our PDC product candidates follows:

Our lead PDC therapeutic, CLR 131 is a small-molecule, PDC designed to providetargeted delivery of iodine-131 directly to cancer cells, while limitingexposure to healthy cells. We believe this profile differentiates CLR 131 frommany traditional on-market treatments and treatments in development. CLR 131 iscurrently being evaluated in a Phase 2 study in r/r B-cell lymphomas, and twoPhase 1 dose-escalating clinical studies, one in r/r MM and one in r/r pediatricsolid tumors and lymphoma. The initial Investigational New Drug (IND)application was accepted by the FDA in March 2014 with multiple INDs submittedsince that time. Initiated in March 2017, the primary goal of the Phase 2 studyis to assess the compound's efficacy in a broad range of hematologic cancers.The Phase 1 study is designed to assess the compound's safety and tolerabilityin patients with r/r MM (to determine maximum tolerated dose) and was initiatedin April 2015. The FDA previously accepted our IND application for a Phase 1open-label, dose escalating study to evaluate the safety and tolerability of asingle intravenous administration of CLR 131 in up to 30 children andadolescents with cancers including neuroblastoma, sarcomas, lymphomas (includingHodgkin's lymphoma) and malignant brain tumors. This study was initiated duringthe first quarter of 2019. These cancer types were selected for clinical,regulatory and commercial rationales, including the radiosensitive nature andcontinued unmet medical need in the r/r setting, and the rare diseasedeterminations made by the FDA based upon the current definition within theOrphan Drug Act.

In December 2014, the FDA granted ODD for CLR 131 for the treatment of MM.Multiple myeloma is an incurable cancer of the plasma cells and is the secondmost common form of hematologic cancers. In 2018, the FDA granted ODD and RPDDfor CLR 131 for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing'ssarcoma and osteosarcoma. The FDA may award priority review vouchers to sponsorsof rare pediatric disease products that meet its specified criteria. The keycriteria to receiving a priority review voucher is that the disease beingtreated is life-threatening and that it primarily effects individuals under theage of 18. Under this program, a sponsor who receives an approval for a drug orbiologic for a rare pediatric disease can receive a priority review voucher thatcan be redeemed to receive a priority review of a subsequent marketingapplication for a different product. Additionally, these priority reviewvouchers can be exchanged or sold to other companies for them to use thevoucher. In May 2019, the FDA granted Fast Track designation for CLR 131 for thetreatment of multiple myeloma in July 2019 for the treatment of DLBCL, inSeptember, CLR 131 received Orphan Drug Designation from the European Union forMultiple Myeloma, and in January 2020, the FDA granted Orphan Drug Designationfor CLR 131 in lymphoplasmacytic lymphoma (LPL).

Phase 2 Study in Patients with r/r select B-cell Malignancies

In February 2020, we announced positive data from our Phase 2 CLOVER-1 study inpatients with relapsed/refractory B-cell lymphomas. Relapsed/Refractory MM andnon-Hodgkin lymphoma (NHL) patients were treated with three different doses(<50mCi, ~50mCi and ~75mCi total body dose (TBD). The <50mCi total body dose wasa deliberately planned sub-therapeutic dose. CLR 131 achieved the primaryendpoint for the study. Patients with r/r MM who received the highest dose ofCLR 131 showed a 42.8% overall response rate (ORR). Those who received ~50mCiTBD had a 26.3% ORR with a combined rate of 34.5% ORR (n=33) while maintaining awell-tolerated safety profile. Patients in the studies were elderly with amedian age of 70, and heavily pre-treated, with a median of five prior lines oftreatment (range: 3 to 17), which included immunomodulatory drugs, proteasomeinhibitors and CD38 antibodies for the majority of patients. Additionally, amajority of the patients (53%) were quad refractory or greater and 44% of alltreated multiple myeloma patients were triple class refractory. 100% of allevaluable patients (n=43) achieved clinical benefit (primary outcome measure) asdefined by having stable disease or better. 85.7% of multiple myeloma patientsreceiving the higher total body dose levels of CLR 131 experienced tumorreduction. The 75mCi TBD demonstrated positive activity in both high-riskpatients and triple class refractory patients with a 50% and 33% ORR,respectively.

Patients with r/r NHL who received ~50mCi TBD and the ~75mCi TBD had a 42% and43% ORR, respectively and a combined rate of 42%. These patients were alsoheavily pre-treated, having a median of three prior lines of treatment (range, 1to 9) with the majority of patients being refractory to rituximab and/oribrutinib. The patients had a median age of 70 with a range of 51 to 86. Allpatients had bone marrow involvement with an average of 23%. In addition tothese findings, subtype assessments were completed in the r/r B-cell NHLpatients. Patients with DLBCL demonstrated a 30% ORR with one patient achievinga complete response (CR), which continues at nearly 24 months post-treatment.The ORR for CLL/SLL/MZL patients was 33%. Current data from our Phase 2 CLOVER-1clinical study show that four LPL/WM patients demonstrated 100% ORR with onepatient achieving a CR which continues at nearly 27 months post-treatment. Thismay represent an important improvement in the treatment of relapsed/refractoryLPL/WM as we believe no approved or late-stage development treatments forsecond- and third-line patients have reported a CR. LPL/WM is a rare, indolentand incurable form of NHL that is composed of a patient population in need ofnew and better treatment options.

The most frequently reported adverse events in r/r MM patients were cytopenias,which followed a predictable course and timeline. The frequency of adverseevents have not increased as doses were increased and the profile of cytopeniasremains consistent. Importantly, these cytopenias have had a predictable patternto initiation, nadir and recovery and are treatable. The most common grade ?3events at the highest dose (75mCi TBD) were hematologic toxicities includingthrombocytopenia (65%), neutropenia (41%), leukopenia (30%), anemia (24%) andlymphopenia (35%). No patients experienced cardiotoxicities, neurologicaltoxicities, infusion site reactions, peripheral neuropathy, allergic reactions,cytokine release syndrome, keratopathy, renal toxicities, or changes in liverenzymes. The safety and tolerability profile in patients with r/r NHL wassimilar to r/r MM patients except for fewer cytopenias of any grade. Based uponCLR 131 being well tolerated across all dose groups and the observed responserate, especially in difficult to treat patients such as high risk and tripleclass refractory or penta-refractory, and corroborating data showing thepotential to further improve upon current ORRs and durability of thoseresponses, the study has been expanded to test a two-cycle dosing optimizationregimen of CLR 131.

In July 2016, we were awarded a $2,000,000National Cancer Institute (NCI)Fast-Track Small Business Innovation Research grant to further advance theclinical development of CLR 131. The funds are supporting the Phase 2 studyinitiated in March 2017 to define the clinical benefits of CLR 131 in r/r MM andother niche hematologic malignancies with unmet clinical need. These nichehematologic malignancies include Chronic Lymphocytic Leukemia, Small LymphocyticLymphoma, Marginal Zone Lymphoma, Lymphoplasmacytic Lymphoma and DLBCL. Thestudy is being conducted in approximately 10 U.S. cancer centers in patientswith orphan-designated relapse or refractory hematologic cancers. The study'sprimary endpoint is clinical benefit response (CBR), with additional endpointsof ORR, progression free survival (PFS,) median Overall Survival (mOS) and othermarkers of efficacy following a single 25.0 mCi/m2 dose of CLR 131, with theoption for a second 25.0 mCi/m2dose approximately 75-180 days later. Based onthe performance results from Cohort 5 of our Phase 1 study in patients with r/rMM, reviewed below, we have modified the dosing regimen of this study to afractionated dose of 15.625 mCi/m2 administered on day 1 and day 8.

In May 2020, we announced that the FDA granted Fast Track Designation for CLR131 in LPL/WM in patients having received two prior treatment regimens or more.

Phase 1 Study in Patients with r/r Multiple Myeloma

In February 2020, we announced the successful completion of our Phase 1 doseescalation study. Data from the study demonstrated that CLR 131 was safe andtolerated at total body dose of approximately 90mCi in r/r MM. The Phase 1multicenter, open-label, dose-escalation study was designed to evaluate thesafety and tolerability of CLR 131 administered as a 30-minute I.V. infusion,either as a single bolus dose or as two fractionated doses. The r/r multiplemyeloma patients in this study received single cycle doses ranging fromapproximately 20mCi to 90mCi total body dose. To date, an independent DataMonitoring Committee determined that all doses have been safe and well-toleratedby patients.

CLR 131 in combination with dexamethasone is currently under investigation inadult patients with r/r MM. Patients must have been refractory to or relapsedfrom at least one proteasome inhibitor and at least one immunomodulatory agent.The clinical study is a standard three-plus-three dose escalation safety studyto determine the maximum tolerable dose. Multiple myeloma is an incurable cancerof the plasma cells and is the second most common form of hematologic cancers.Secondary objectives include the evaluation of therapeutic activity by assessingsurrogate efficacy markers, which include M protein, free light chain (FLC), PFSand OS. All patients have been heavily pretreated with an average of five priorlines of therapy. CLR 131 was deemed by an Independent Data Monitoring Committee(IDMC) to be safe and tolerable up to its planned maximum single, bolus dose of31.25 mCi/m2. The four single dose cohorts examined were: 12.5 mCi/m2(~25mCiTBD), 18.75 mCi/m2 (~37.5mCi TBD), 25 mCi/m2(~50mCi TBD), and 31.25mCi/m2(~62.5mCi TBD), all in combination with low dose dexamethasone (40 mgweekly). Of the five patients in the first cohort, four achieved stable diseaseand one patient progressed at Day 15 after administration and was taken off thestudy. Of the five patients admitted to the second cohort, all five achievedstable disease however one patient progressed at Day 41 after administration andwas taken off the study. Four patients were enrolled to the third cohort and allachieved stable disease. In September 2017, we announced results for cohort 4,showing that a single infusion up to 30-minutes of 31.25mCi/m2 of CLR 131 wassafe and tolerated by the three patients in the cohort. Additionally, all threepatients experienced CBR with one patient achieving a partial response (PR). Weuse the International Myeloma Working Group (IMWG) definitions of response,which involve monitoring the surrogate markers of efficacy, M protein and FLC.The IMWG defines a PR as a greater than or equal to 50% decrease in FLC levels(for patients in whom M protein is unmeasurable) or 50% or greater decrease in Mprotein. The patient experiencing a PR had an 82% reduction in FLC. This patientdid not produce M protein, had received seven prior lines of treatment includingradiation, stem cell transplantation and multiple triple combination treatmentsincluding one with daratumumab that was not tolerated. One patient experiencingstable disease attained a 44% reduction in M protein. In January 2019, weannounced that the pooled mOS data from the first four cohorts was 22.0 months.In late 2018, we modified this study to evaluate a fractionated dosing strategyto potentially increase efficacy and decrease adverse events.

Following the determination that all prior dosing cohorts were safe andtolerated, we initiated a cohort 7 utilizing a 40mCi/m2 fractionated doseadministered 20mCi/m2 (~40mCi TBD) on days 1 and day 8. Cohort 7 was the highestpre-planned dose cohort and subjects have completed the evaluation period. Finalstudy report and study close-out will be completed later this year.

In May 2019, we announced that the FDA granted Fast Track Designation for CLR131 in fourth line or later r/r MM. CLR 131 is our small-moleculeradiotherapeutic PDC designed to deliver cytotoxic radiation directly andselectively to cancer cells and cancer stem cells. It is currently beingevaluated in our ongoing CLOVER-1 Phase 2 clinical study in patients withrelapsed or refractory multiple myeloma and other select B-cell lymphomas.

Phase 1 Study in r/r Pediatric Patients with select Solid tumors, Lymphomas andMalignant Brain Tumors

In December 2017 the Division of Oncology at the FDA accepted our IND and studydesign for the Phase 1 study of CLR 131 in children and adolescents with selectrare and orphan designated cancers. This study was initiated during the firstquarter of 2019. In December 2017, we filed an IND application for r/r pediatricpatients with select solid tumors, lymphomas and malignant brain tumors. ThePhase 1 clinical study of CLR 131 is an open-label, sequential-group,dose-escalation study evaluating the safety and tolerability of intravenousadministration of CLR 131 in up to 30 children and adolescents with cancersincluding neuroblastoma, sarcomas, lymphomas (including Hodgkin's lymphoma) andmalignant brain tumors. Secondary objectives of the study are to identify therecommended Phase 2 dose of CLR 131 and to determine preliminary antitumoractivity (treatment response) of CLR 131 in children and adolescents. In 2018,the FDA granted OD and RPDD for CLR 131 for the treatment of neuroblastoma,rhabdomyosarcoma, Ewing's sarcoma and osteosarcoma. Should any of theseindications reach approval, the RPDD would enable us to receive a priorityreview voucher. Priority review vouchers can be used by the sponsor to receivepriority review for a future New Drug Application ("NDA") or Biologic LicenseApplication ("BLA") submission, which would reduce the FDA review time from 12months to six months. Currently, these vouchers can also be transferred or soldto another entity.

Phase 1 Study in r/r Head and Neck Cancer

In August 2016, the University of Wisconsin Carbone Cancer Center ("UWCCC") wasawarded a five-year Specialized Programs of Research Excellence ("SPORE") grantof $12,000,000 from the National Cancer Institute and the National Institute ofDental and Craniofacial Research to improve treatments and outcomes for head andneck cancer, HNC, patients. HNC is the sixth most common cancer across the worldwith approximately 56,000 new patients diagnosed every year in the U.S. As a keycomponent of this grant, the UWCCC researchers completed testing of CLR 131 invarious animal HNC models and initiated the first human clinical trial enrollingup to 30 patients combining CLR 131 and external beam radiation with recurrentHNC in Q4 2019. This clinical trial was suspended due to the COVID-19 pandemicbut has now been reopened for enrolment.

We believe our PDC platform has potential to provide targeted delivery of adiverse range of oncologic payloads, as exemplified by the product candidateslisted below, that may result in improvements upon current standard of care("SOC") for the treatment of a broad range of human cancers:

Research and development expense. Research and development expense consist ofcosts incurred in identifying, developing and testing, and manufacturing productcandidates, which primarily include salaries and related expenses for personnel,cost of manufacturing materials and contract manufacturing fees paid to contractmanufacturers and contract research organizations, fees paid to medicalinstitutions for clinical trials, and costs to secure intellectual property. TheCompany analyzes its research and development expenses based on four categoriesas follows: clinical project costs, preclinical project costs, manufacturing andrelated costs, and general research and development costs that are not allocatedto the functional project costs, including personnel costs, facility costs,related overhead costs and patent costs.

General and administrative expense. General and administrative expense consistsprimarily of salaries and other related costs for personnel in executive,finance and administrative functions. Other costs include insurance, costs forpublic company activities, investor relations, directors' fees and professionalfees for legal and accounting services.

Three Months Ended June 30, 2020 and 2019

Research and Development. Research and development expense for the three monthsended June 30, 2020 was approximately $2,465,000 compared to approximately$1,810,000 for the three months ended June 30, 2019.

The following table is an approximate comparison summary of research anddevelopment costs for the three months ended June 30, 2020 and June 30, 2019:

General research and development costs 1,018,000 384,000 634,000

The overall increase in research and development expense of $655,000, or 36%,was primarily a result of increased general research and development costsresulting from increased personnel related costs and in clinical project costs.Manufacturing and related costs decreased due to a decrease in materialsproduction processes and related costs. Pre-clinical study costs were relativelyconsistent.

General and administrative. General and administrative expense for the threemonths ended June 30, 2020 was approximately $1,157,000, compared toapproximately $1,391,000 in the three months ended June 30, 2019. The decreaseof approximately $234,000, or 17%, was primarily a result of lower stock-basedcompensation expense.

Six Months Ended June 30, 2020 and 2019

Research and Development. Research and development expense for the six monthsended June 30, 2020 was approximately $5,082,000 compared to approximately$4,118,000 for the six months ended June 30, 2019.

The following table is a comparison summary of research and development costsfor the six months ended June 30, 2020 and June 30, 2019:

General research and development costs 1,779,000 914,000 865,000

The overall increase in research and development expense of approximately$964,000, or 23%, was primarily a result of increased general research anddevelopment costs resulting from increased personnel related costs and inclinical project costs. Manufacturing and related costs decreased due to adecrease in materials production processes and related costs. Pre-clinical studycosts were relatively consistent.

General and Administrative. General and administrative expense for the sixmonths ended June 30, 2020 was approximately $2,499,000, compared toapproximately $2,712,000 in the six months ended June 30, 2019. The decrease ofapproximately $213,000, or 8%, was primarily a result of lower stock-basedcompensation expense.

Liquidity and Capital Resources

As of June 30, 2020, we had cash and cash equivalents of approximately$22,450,000 compared to $10,615,000 as of December 31, 2019. This increase wasdue primarily to the approximately $18,300,000 of net proceeds received inconnection with the June 5, 2020 public offering. Net cash used in operatingactivities during the six months ended June 30, 2020 was approximately$6,562,000.

Our cash requirements have historically been for our research and developmentactivities, finance and administrative costs, capital expenditures and overallworking capital. We have experienced negative operating cash flows sinceinception and have funded our operations primarily from sales of common stockand other securities. As of June 30, 2020, we had an accumulated deficit ofapproximately $119,251,000.

We believe that the cash balance is adequate to fund our basic budgetedoperations for at least 12 months from the filing of these financial statements.However, our future results of operations involve significant risks anduncertainties. Our ability to execute our operating plan beyond that timedepends on our ability to obtain additional funding via the sale of equityand/or debt securities, a strategic transaction or otherwise. We plan toactively pursue all available financing alternatives; however, there can be noassurance that we will obtain the necessary funding. Other than theuncertainties regarding our ability to obtain additional funding, there arecurrently no known trends, demands, commitments, events or uncertainties thatare likely to materially affect our liquidity. Because we have had recurringlosses and negative cash flows from operating activities, and in light of ourexpected expenditures, the report of our independent auditors with respect tothe financial statements as of December 31, 2019 and for the year ended December31, 2019 contains an explanatory paragraph as to the potential inability tocontinue as a going concern. This opinion indicated at that time, thatsubstantial doubt existed regarding our ability to remain in business.

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