AGC Biologics Confirms Cell and Gene Therapy Commercial Expertise as Manufacturer of Orchard Therapeutics’ Newly Approved Libmeldy(TM) – Daily…
By daniellenierenberg
SEATTLE, Jan. 4, 2021 /PRNewswire/ -- AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), is the first manufacturer of Orchard Therapeutics' Libmeldy, which was recently approved by the European Commission (EC) as a one-time therapy for eligible patients with early-onset Metachromatic Leukodystrophy (MLD).
The EC has granted full (standard) market authorization for Libmeldy (autologous CD34+ cells encoding the ARSA gene), a lentiviral vector-based gene therapy manufactured at AGC Biologics' Milan facility. Orchard Therapeutics is already underway with EU launch preparations to support commercial-scale drug manufacturing at the AGC Biologics Milan facility.
"AGC Biologics is delighted to have successfully partnered with Orchard Therapeutics on this great milestone," says AGC Biologics Chief Business Officer, Mark Womack. "We're very proud to be one of few Cell and Gene Therapy CDMOs with commercial experience Libmeldy being the third commercial product we've manufactured and we look forward to continuing our partnership with Orchard to provide this life-changing therapy to those affected by MLD."
"We are very honored to have been a part of the entire clinical journey of this product, from the very first treated patient, all the way to market approval. As manufacturer of both lentiviral vector and drug product, we are proud to support Orchard in treating this devastating disease," says AGC Biologics General Manager of Milan, Luca Alberici.
"The EC approval of Libmeldy opens up tremendous possibilities for eligible MLD children faced with this devastating disease," saysBobby Gaspar, M.D., Ph.D., Chief Executive Officer of Orchard. "We are humbled by the opportunity to bring this remarkable innovation to young eligible patients in the EU, and confident in the capabilities of our partners at AGC Biologics to help us achieve this goal."
MLD is a rare neurodegenerative disorder caused by mutations in the ARSA gene. While there are several forms of MLD, the disorder primarily affects young children and disease progression and life expectancy varies based on age of symptom onset. Libmeldy is designed to correct the genetic cause of MLD by inserting functional copies of the ARSA gene into the genome of a patient's own hematopoietic stem cells (HSCs) using a self-inactivating (SIN) lentiviral vector. It is approved in the EU for children with i) late infantile or early juvenile forms, without clinical manifestations of the disease, or ii) the early juvenile form, with early clinical manifestations of the disease, who still have the ability to walk independently and before the onset of cognitive decline. Libmeldy is the first therapy approved for eligible patients with early-onset MLD.
About AGC Biologics: AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to deliver the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), viral vectors and genetically engineered cells. Our global network spans the U.S., Europe and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan and we currently employ more than 1,600 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients' most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit http://www.agcbio.com.
About Orchard Therapeutics:Orchard Therapeutics is a global gene therapy leader dedicated to transforming the lives of people affected by rare diseases through the development of innovative, potentially curative gene therapies. Our ex vivo autologous gene therapy approach harnesses the power of genetically modified blood stem cells and seeks to correct the underlying cause of disease in a single administration. In 2018, Orchard acquired GSK's rare disease gene therapy portfolio, which originated from a pioneering collaboration between GSK and the San Raffaele Telethon Institute for Gene Therapy in Milan, Italy. Orchard now has one of the deepest and most advanced gene therapy product candidate pipelines in the industry spanning multiple therapeutic areas where the disease burden on children, families and caregivers is immense and current treatment options are limited or do not exist.
Orchard has its global headquarters in London and U.S. headquarters in Boston. For more information, please visit http://www.orchard-tx.com, and follow us onTwitterandLinkedIn.
About OTL-200/Libmeldy:Libmeldy (autologous CD34+ cell enriched population that contains hematopoietic stem and progenitor cells (HSPC) transduced ex vivo using a lentiviral vector encoding the human arylsulfatase-A (ARSA) gene), also known as OTL-200, is approved in the European Union (as appropriate may add: "UK, Iceland, Liechtenstein and Norway" as an alternative can rewrite as "was approved by the European Commission" or something similar) for the treatment of MLD in eligible early-onset patients characterized by biallelic mutations in the ARSA gene leading to a reduction of the ARSA enzymatic activity in children with i) late infantile or early juvenile forms, without clinical manifestations of the disease, or ii) the early juvenile form, with early clinical manifestations of the disease, who still have the ability to walk independently and before the onset of cognitive decline. Libmeldy is the first therapy approved for eligible patients with early-onset MLD.
The most common adverse reaction attributed to treatment with Libmeldy was the occurrence of anti-ARSA antibodies (AAA). In addition to the risks associated with the gene therapy, treatment with Libmeldy is preceded by other medical interventions, namely bone marrow harvest or peripheral blood mobilization and apheresis, followed by myeloablative conditioning, which carry their own risks. During the clinical studies, the safety profiles of these interventions were consistent with their known safety and tolerability.
For more information about Libmeldy, please see the Summary of Product Characteristics (SmPC).
Libmeldy is not approved outside of the European Union, UK, Iceland, Liechtenstein and Norway. OTL-200 is an investigational therapy, which has not been approved by the U.S. Food and Drug Administration or any other health authority.
OTL-200 was developed in partnership with the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget) in Milan, Italy.
Stem Cell Therapy Market by Treatment,Application,End Users and Geography Forecast To 2027 – LionLowdown
By daniellenierenberg
Stem Cell Therapy Market is expected to reach 202.77 billion by 2027 from XX billion in 2019 at CAGR of XX %.
The report includes the analysis of impact of COVID-19 lock-down on the revenue of market leaders, followers, and disrupters. Since lock down was implemented differently in different regions and countries, impact of same is also different by regions and segments. The report has covered the current short term and long term impact on the market, same will help decision makers to prepare the outline for short term and long term strategies for companies by region.
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.
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 Companies
DO INQUIRY BEFORE PURCHASING REPORT HERE: https://www.maximizemarketresearch.com/inquiry-before-buying/522
Scope 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
MAJOR TOC OF THE REPORT
Chapter One: Stem Cell Therapy Market Overview
Chapter Two: Manufacturers Profiles
Chapter Three: Global Stem Cell Therapy Market Competition, by Players
Chapter Four: Global Stem Cell Therapy Market Size by Regions
Chapter Five: North America Stem Cell Therapy Revenue by Countries
Chapter Six: Europe Stem Cell Therapy Revenue by Countries
Chapter Seven: Asia-Pacific Stem Cell Therapy Revenue by Countries
Chapter Eight: South America Stem Cell Therapy Revenue by Countries
Chapter Nine: Middle East and Africa Revenue Stem Cell Therapy by Countries
Chapter Ten: Global Stem Cell Therapy Market Segment by Type
Chapter Eleven: Global Stem Cell Therapy Market Segment by Application
Chapter Twelve: Global Stem Cell Therapy Market Size Forecast (2019-2026)
Browse Full Report with Facts and Figures of Stem Cell Therapy Market Report at: https://www.maximizemarketresearch.com/market-report/stem-cell-therapy-market/522/
About Us:
Maximize Market Research provides B2B and B2C market research on 20,000 high growth emerging technologies & opportunities in Chemical, Healthcare, Pharmaceuticals, Electronics & Communications, Internet of Things, Food and Beverages, Aerospace and Defense and other manufacturing sectors.
Contact info:
Name: Vikas Godage
Organization: MAXIMIZE MARKET RESEARCH PVT. LTD.
Email: [emailprotected]
Contact: +919607065656/ +919607195908
Website:www.maximizemarketresearch.com
Here is the original post:
Stem Cell Therapy Market by Treatment,Application,End Users and Geography Forecast To 2027 - LionLowdown
MorphoSys and Incyte Announce the Acceptance of the Swissmedic Marketing Authorization Application f – PharmiWeb.com
By daniellenierenberg
DGAP-News: MorphoSys AG / Key word(s): Miscellaneous05.01.2021 / 08:00 The issuer is solely responsible for the content of this announcement.
Media Release
MorphoSys and Incyte Announce the Acceptance of the Swissmedic Marketing Authorization Application for Tafasitamab
- The Swissmedic MAA seeks approval for tafasitamab in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma
PLANEGG/MUNICH, Germany and MORGES, Switzerland - January 5, 2021 - MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) and Incyte (NASDAQ:INCY) today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has accepted the marketing authorization application (MAA) for tafasitamab, a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. The MAA seeks approval for tafasitamab, in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, who are not candidates for autologous stem cell transplantation (ASCT). The MAA will now enter the formal review process by Swissmedic.
The Swissmedic MAA for tafasitamab will be reviewed as part of the U.S. Food and Drug Administration's (FDA) modified Project Orbis, which provides a framework for concurrent submission and review of oncology drug applications among the FDA's international collaborators. Collaboration among international regulators may allow patients with cancer to receive earlier access to products in other countries.
"Currently about 40% of DLBCL patients do not respond to initial therapy or relapse thereafter leading to a high medical need for new, effective therapies," said Peter Langmuir, M.D., Group Vice President, Targeted Therapeutics, Incyte. "The acceptance of the MAA for tafasitamab for review by Swissmedic is a pivotal step towards bringing tafasitamab in combination with lenalidomide to eligible patients in Switzerland."
"Tafasitamab in combination with lenalidomide may represent an important new targeted treatment option for patients with relapsed or refractory DLBCL," said Mike Akimov, M.D., Ph.D., Head of Global Clinical Development, MorphoSys. "We look forward to continuing to work with the regulatory authorities alongside our partners at Incyte to bring this novel therapeutic option to eligible patients with a high unmet medical need."
The Swissmedic application, submitted by Incyte in collaboration with MorphoSys, is supported by data from the L-MIND study evaluating tafasitamab in combination with lenalidomide as a treatment for patients with relapsed or refractory DLBCL and data from the RE-MIND study, an observational retrospective study in relapsed or refractory DLBCL. If approved, Incyte will hold the marketing authorization, and have exclusive commercialization rights for tafasitamab in Switzerland.
Incyte has exclusive commercialization rights for tafasitamab outside the United States.
About Diffuse Large B-cell Lymphoma (DLBCL)DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide[1], characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs. It is an aggressive disease with about 40% of patients not responding to initial therapy or relapsing thereafter[2]. In Europe, each year approximately 16,000 patients are diagnosed with relapsed or refractory DLBCL[3],[4],[5].
About L-MINDThe L-MIND trial is a single arm, open-label, multicenter Phase 2 study (NCT02399085) investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have had at least one, but no more than three prior lines of therapy, including an anti-CD20 targeting therapy (e.g. rituximab), who are not eligible for high-dose chemotherapy or refuse subsequent autologous stem cell transplant. The study's primary endpoint is Overall Response Rate (ORR). Secondary outcome measures include Duration of Response (DoR), Progression-Free Survival (PFS) and Overall Survival (OS). In May 2019, the study reached its primary completion.
For more information about L-MIND, visit https://clinicaltrials.gov/ct2/show/NCT02399085
About RE-MINDRE-MIND, an observational retrospective study (NCT04150328), was designed to isolate the contribution of tafasitamab in combination with lenalidomide and to prove the combinatorial effect. The study compares real-world response data of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received lenalidomide monotherapy with the efficacy outcomes of the tafasitamab-lenalidomide combination, as investigated in MorphoSys' L-MIND trial. RE-MIND collected the efficacy data from 490 relapsed or refractory DLBCL patients in the U.S. and the EU. Qualification criteria for matching patients of both studies were pre-specified. As a result, 76 eligible RE-MIND patients were identified and matched 1:1 to 76 of 80 L-MIND patients based on important baseline characteristics. Objective Response Rates (ORR) were validated based on this subset of 76 patients in RE-MIND and L-MIND, respectively. The primary endpoint of RE-MIND was met and shows a statistically significant superior best ORR of the tafasitamab-lenalidomide combination compared to lenalidomide monotherapy.
For more information about RE-MIND, visit https://clinicaltrials.gov/ct2/show/NCT04150328.
About TafasitamabTafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).
Monjuvi(R) (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration (FDA) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.
Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.
Monjuvi(R) is a registered trademark of MorphoSys AG.
XmAb(R) is a registered trademark of Xencor, Inc.
About MorphoSysMorphoSys (FSE & NASDAQ: MOR) is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of exceptional, innovative therapies for patients suffering from serious diseases. The focus is on cancer. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development. In 2017, Tremfya(R), developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc., for the treatment of plaque psoriasis, became the first drug based on MorphoSys' antibody technology to receive regulatory approval. In July 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval of MorphoSys' proprietary product Monjuvi(R) (tafasitamab-cxix) in combination with lenalidomide in patients with a certain type of lymphoma.
Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has ~500 employees. More information at http://www.morphosys.com or http://www.morphosys-us.com.
Monjuvi(R) is a registered trademark of MorphoSys AG.
Tremfya(R) is a registered trademark of Janssen Biotech, Inc.
About Incyte Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.
MorphoSys Forward-looking Statements This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including the expectations regarding Monjuvi's ability to treat patients with relapsed or refractory diffuse large B-cell lymphoma, the further clinical development of tafasitamab-cxix, including ongoing confirmatory trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "would," "could," "potential," "possible," "hope" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are MorphoSys' expectations regarding risks and uncertainties related to the impact of the COVID-19 pandemic to MorphoSys' business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of current or future approved products, and launching, marketing and selling current or future approved products, the global collaboration and license agreement for tafasitamab, the further clinical development of tafasitamab, including ongoing confirmatory trials, and MorphoSys' ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi, MorphoSys' reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys' Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.
Incyte Forward-looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding whether or when tafasitamab might be approved in Switzerland for the treatment of, and whether or when tafasitamab might provide a successful treatment option for, in combination with lenalidomide, certain patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), and the L-MIND and RE-MIND clinical trial programs. These forward-looking statements are based on the Company's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by European regulatory authorities or other regulatory authorities, including the U.S. FDA; the Company's dependence on its relationships with its collaboration partners; the efficacy or safety of the Company's products and the products of the Company's collaboration partners; the acceptance of the Company's products and the products of the Company's collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ending September 30, 2020. The Company disclaims any intent or obligation to update these forward-looking statements. # # #
Contacts:
References[1] Sarkozy C, et al. Management of relapsed/refractory DLBCL. Best Practice Research & Clinical Haematology. 2018 31:209-16. doi.org/10.1016/j.beha.2018.07.014.[2] Skrabek P, et al. Emerging therapies for the treatment of relapsed or refractory diffuse large B cell lymphoma. Current Oncology. 2019 26(4): 253-265. doi.org/10.3747/co.26.5421.[3] DRG Epidemiology data.[4] Kantar Market Research (TPP testing 2018).[5] Friedberg, Jonathan W. Relapsed/Refractory Diffuse Large B-Cell Lymphoma. Hematology Am Soc Hematol Educ Program 2011; 2011:498-505. doi: 10.1182/asheducation-2011.1.498.
05.01.2021 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.The issuer is solely responsible for the content of this announcement.
The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at http://www.dgap.de
Read the original:
MorphoSys and Incyte Announce the Acceptance of the Swissmedic Marketing Authorization Application f - PharmiWeb.com
Worldwide Industry for Biopreservation to 2026 – Key Drivers, Restraints and Opportunities – Yahoo Finance
By daniellenierenberg
DUBLIN, Jan. 4, 2021 /PRNewswire/ -- The "Biopreservation Market by Type, Application, End-user, and Geography - Global Forecast to 2026" report has been added to ResearchAndMarkets.com's offering.
Biopreservation is a process that assists in the conservation of biospecimens such as DNA, saliva, and plasma. This process of biopreservation generally increases the durability, shelf life, and purity of the biosamples. The types of equipment in this process include freezers, liquid nitrogen, consumables, and also media & laboratory information management systems.
This process is also used to preserve food and extend its shelf life, specifically by using lactic acid bacteria. Growth in healthcare spending is assumed for better access to quality healthcare and advanced technology products such as biopreservation facilities, thereby widening the growth expectations. Moreover, the bio-banks, hospitals, and gene banks, which are major end-users for this market, are stimulating the key providers to establish technologically advanced biopreservation products to improve patient outcomes. The Biopreservation Market is projected to grow at a rate of 9.2% CAGR by 2026.
The biopreservation market has been analyzed by utilizing the optimum combination of secondary sources and in-house methodology, along with an irreplaceable blend of primary insights. The real-time assessment of the market is an integral part of our market sizing and forecasting methodology. Our industry experts and panel of primary participants have helped in compiling relevant aspects with realistic parametric estimations for a comprehensive study. The participation share of different categories of primary participants is given below:
In the market for biopreservation, the application of biopreservation consists of therapeutic applications, research applications, clinical trials, and other applications. The biopreservation is primarily applied in therapeutics due to the advancements in regenerative medicine & customized medicine, an increase in the shift of cord blood banking, and the rising incidence of chronic diseases.
The end-users of the biopreservation market include biobanks, gene banks, hospitals, and other end users. The biobanks segment is expected to have a major share in the market. The major share of this segment is attributed to the increasing preference for the preservation of stem cells and the rising numbers of sperm and egg banks.
Further, according to the regional market of biopreservation, the North American region is recorded for the colossal share in the market. This is due to the continuous drug developments and the arrival of advanced therapies in the domain of biomedical research. Additionally, the increasing requirement of expensive and improved treatment for patients' chronic diseases is the key factor.
The rising incidence of chronic diseases, including cardiac, renal diseases, diabetes, and obesity, is the crucial factor that will propel the biopreservation market growth in the prevailing period. Government initiatives to encourage stem cell therapies to treat the disease, which will again propel market growth. Conversely, the strict regulations for producing biopreservation products and the evolution of room temperature storage procedures may limit the biopreservation market growth.
Merck KGaA, Avantor, Inc., Bio-Techne Corporation, BioLife Solutions, Inc., Thermo Fisher Scientific Inc, ThermoGenesis Holdings, Inc., Worthington Industries, Inc., Chart Industries, Inc, So-Low Environmental Equipment Co., Inc., Princeton BioCision, LLC, Shanghai Genext Medical Technology Co. Ltd, Exact Sciences Corporation, Helmer Scientific, Inc., CryoTech, Inc., Arctiko, Nippon Genetics Europe, PHC Holdings Corporation, STEMCELL Technologies, Inc., AMS Biotechnology, and OPS Diagnostics. These are the few companies list of the biopreservation market.
Since the rapid increase in the number of research and developments gives the way of potentials for market growth, the biopreservation of biological samples has become a crucial segment. This helps the researchers to access the data of the number of people by the preserved biological samples.
This research presents a thorough analysis of market share, the present trends, and forthcoming evaluations to explain the approaching investment pockets.
This research provides market insights from 2020 to 2026, which is predicted to allow the shareholders to capitalize on the forthcoming opportunities.
This report further offers comprehensive insights into the region, which helps to understand the geographical market and assist in strategic business planning and ascertain future opportunities.
Key Topics Covered:
1. Executive Summary
2. Industry Outlook2.1. Industry Overview2.2. Industry Trends
3. Market Snapshot3.1. Market Definition3.2. Market Outlook3.2.1. PEST Analysis3.2.2. Porter Five Forces3.3. Related Markets
4. Market characteristics4.1. Market Evolution4.2. Market Trends and Impact4.3. Advantages/Disadvantages of Market4.4. Regulatory Impact4.5. Market Offerings4.6. Market Segmentation4.7. Market Dynamics4.7.1. Drivers4.7.2. Restraints4.7.3. Opportunities4.8. DRO - Impact Analysis
5. Type: Market Size & Analysis5.1. Overview5.2. Biopreservation Media5.2.1. Nutrient Media5.2.2. Sera5.2.3. Growth Factors & Supplements5.3. Biospecimen Equipment5.3.1. Temperature Control Systems5.4. Freezers5.5. Cryogenic Storage Systems5.6. Thawing Equipment5.7. Refrigerators5.7.1. Accessories5.7.2. Alarms & Monitoring systems5.7.3. Incubators5.7.4. Centrifuges5.7.5. Other Equipment
6. Application: Market Size & Analysis6.1. Overview6.2. Therapeutic Applications6.3. Research Applications6.4. Clinical Trials6.5. Other Applications
7. End User: Market Size & Analysis7.1. Overview7.2. Biobanks7.3. Gene Banks7.4. Hospitals7.5. Other End Users
8. Geography: Market Size & Analysis8.1. Overview8.2. North America8.3. Europe8.4. Asia Pacific8.5. Rest of the World
9. Competitive Landscape9.1. Competitor Comparison Analysis9.2. Market Developments9.2.1. Mergers and Acquisitions, Legal, Awards, Partnerships9.2.2. Product Launches and execution
10. Vendor Profiles10.1. Merck KGaA10.1.1. Overview10.1.2. Financials10.1.3. Products & Services10.1.4. Recent Developments10.1.5. Business Strategy10.2. Avantor, Inc10.2.1. Overview10.2.2. Financials10.2.3. Products & Services10.2.4. Recent Developments10.2.5. Business Strategy10.3. Bio-Techne Corporation10.3.1. Overview10.3.2. Financials10.3.3. Products & Services10.3.4. Recent Developments10.3.5. Business Strategy10.4. BioLife Solutions, Inc10.4.1. Overview10.4.2. Financials10.4.3. Products & Services10.4.4. Recent Developments10.4.5. Business Strategy10.5. Thermo Fisher Scientific Inc10.5.1. Overview10.5.2. Financials10.5.3. Products & Services10.5.4. Recent Developments10.5.5. Business Strategy10.6. ThermoGenesis Holdings, Inc10.6.1. Overview10.6.2. Financials10.6.3. Products & Services10.6.4. Recent Developments10.6.5. Business Strategy10.7. Worthington Industries, Inc10.7.1. Overview10.7.2. Financials10.7.3. Products & Services10.7.4. Recent Developments10.7.5. Business Strategy10.8. Chart Industries, Inc10.8.1. Overview10.8.2. Financials10.8.3. Products & Services10.8.4. Recent Developments10.8.5. Business Strategy10.9. So-Low Environmental Equipment Co.,Inc10.9.1. Overview10.9.2. Financials10.9.3. Products & Services10.9.4. Recent Developments10.9.5. Business Strategy10.10. Princeton BioCision, LLC10.10.1. Overview10.10.2. Financials10.10.3. Products & Services10.10.4. Recent Developments10.10.5. Business Strategy
11. Companies to Watch11.1. Shanghai Genext Medical Technology Co. Ltd11.1.1. Overview11.1.2. Products & Services11.1.3. Business Strategy11.2. Exact Sciences Corporation11.2.1. Overview11.2.2. Products & Services11.2.3. Business Strategy11.3. Helmer Scientific, Inc11.3.1. Overview11.3.2. Products & Services11.3.3. Business Strategy11.4. CryoTech, Inc11.4.1. Overview11.4.2. Products & Services11.4.3. Business Strategy11.5. Arctiko11.5.1. Overview11.5.2. Products & Services11.5.3. Business Strategy11.6. Nippon Genetics Europe11.6.1. Overview11.6.2. Products & Services11.6.3. Business Strategy11.7. PHC Holdings Corporation11.7.1. Overview11.7.2. Products & Services11.7.3. Business Strategy11.8. STEMCELL Technologies, Inc11.8.1. Overview11.8.2. Products & Services11.8.3. Business Strategy11.9. AMS Biotechnology11.9.1. Overview11.9.2. Products & Services11.9.3. Business Strategy11.10. OPS Diagnostics11.10.1. Overview11.10.2. Products & Services11.10.3. Business Strategy
12. Analyst Opinion
13. Annexure13.1. Report Scope13.2. Market Definitions13.3. Research Methodology13.3.1. Data Collation and In-house Estimation13.3.2. Market Triangulation13.3.3. Forecasting13.4. Report Assumptions13.5. Declarations13.6. Stakeholders13.7. Abbreviations
For more information about this report visit https://www.researchandmarkets.com/r/711zgr
Story continues
Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.
Media Contact:
Research and Markets Laura Wood, Senior Manager press@researchandmarkets.com
For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716
View original content:http://www.prnewswire.com/news-releases/worldwide-industry-for-biopreservation-to-2026---key-drivers-restraints-and-opportunities-301200103.html
SOURCE Research and Markets
Originally posted here:
Worldwide Industry for Biopreservation to 2026 - Key Drivers, Restraints and Opportunities - Yahoo Finance
2021: What are the best self-care products to buy in the new year? – The Jerusalem Post
By daniellenierenberg
Start the new year with a sweet treat, warm up your feet and dont forget to look glamorous even if all you do is stay home. Heres to 2021! We have high hopes for you...Lierac Paris's anti-aging premium La Cure Absolute. (Photo credit: Courtesy)28 DAYS TO NEW SKINRelatively new in Israel, the French cosmetic brand Lierac Paris launches its flagship product the anti-aging premium La Cure Absolute, a serum that really makes a difference. According to the company, this is a scientific breakthrough developed in their labs together with Harvard University after 25 years of research. The product has seven different registered patents inspired by anti-aging research and based on micro-emulsions and GDF 11 technology. The new technology promotes cell renewal of up to 50%. The rehabilitation is quick 28 days and the results are quite dramatic. We have been using the serum for a week and already see the difference. The product is especially effective in treating tired-looking skin and deep lines, giving skin a shot of energy and also treating pigmentation. Use morning and evening before your hydrating cream. NIS 599, available in clinics and beauty centers. For more information go to http://www.lierac.co.ilGlamGlow youth potion. (Photo credit: Courtesy)ALL THAT GLAMOpen the year looking more glamorous than ever with Hollywoods most glamorous brand, GlamGlow. Their latest launch is the Youthpotion Rejuvenating Peptide Serum, which promises to add glamour to your look from the first application. Thanks to raspberry stem-cells, hyaluronic acid and red seaweed, this light serum will add a youthful glow to your face and make you feel more glamorous, even if all you wear these days is pyjamas. The texture is light and serum absorbs quickly. Use morning and evening with hydrating cream. NIS 349, available in Superpharm, Mashbir, Be and April stores.
cnxps.cmd.push(function () { cnxps({ playerId: '36af7c51-0caf-4741-9824-2c941fc6c17b' }).render('4c4d856e0e6f4e3d808bbc1715e132f6'); });
Original post:
2021: What are the best self-care products to buy in the new year? - The Jerusalem Post
Global Cell Therapy Market Report 2020: Market to Recover in 2023 – PRNewswire
By daniellenierenberg
DUBLIN, Dec. 31, 2020 /PRNewswire/ -- The "Cell Therapy Global Market Report 2020-30: COVID-19 Growth and Change" report has been added to ResearchAndMarkets.com's offering.
Cell Therapy Global Market Report 2020-30: COVID 19 Growth and Change provides the strategists, marketers and senior management with the critical information they need to assess the global cell therapy market.
Major players in the cell therapy market are Fibrocell Science Inc., JCR Pharmaceuticals Co. Ltd., PHARMICELL Co. Ltd., Osiris Therapeutics Inc., MEDIPOST, Vericel Corporation, Anterogen Co. Ltd., Kolon TissueGene Inc., Stemedica Cell Technologies Inc. and AlloCure.
The global cell therapy market is expected to decline from $7.31 billion in 2019 to $7.2 billion in 2020 at a compound annual growth rate (CAGR) of -1.54%. The decline is mainly due to the COVID-19 outbreak that has led to restrictive containment measures involving social distancing, remote working, and the closure of industries and other commercial activities resulting in operational challenges. The entire supply chain has been disrupted, impacting the market negatively. The market is then expected to recover and reach $10.0 billion in 2023 at a CAGR of 11.55%.
The cell therapy market consists of sales of cell therapy and related services. Cell therapy (CT) helps repair or replace damaged tissues and cells. A variety of cells are used for the treatment of diseases includes skeletal muscle stem cells, hematopoietic (blood-forming) stem cells (HSC), lymphocytes, mesenchymal stem cells, pancreatic islet cells, and dendritic cells.
North America was the largest region in the cell therapy market in 2019. Asia Pacific is expected to be the fastest-growing region in the forecast period.
The cell therapy market covered in this report is segmented by technique into stem cell therapy; cell vaccine; adoptive cell transfer (ACT); fibroblast cell therapy; chondrocyte cell therapy. It is also segmented by therapy type into allogeneic therapies; autologous therapies, by application into oncology; cardiovascular disease (CVD); orthopedic; wound healing; others.
In August 2019, Bayer AG, a Germany-based pharmaceutical and life sciences company, acquired BlueRock Therapeutics, an engineered cell therapy company, for $1 billion. Through this transaction, Bayer AG will acquire complete BlueRock Therapeutics' CELL+GENE platform, including a broad intellectual property portfolio and associated technology platform including proprietary iPSC technology, gene engineering, and cell differentiation capabilities. BlueRock Therapeutics is a US-based biotechnology company focused on developing engineered cell therapies in the fields of neurology, cardiology, and immunology, using a proprietary induced pluripotent stem cell (iPSC) platform.
The high cost of cell therapy hindered the growth of the cell therapy market. Cell therapies have become a common choice of treatment in recent years as people are looking for the newest treatment options. Although there is a huge increase in demand for cell therapies, they are still very costly to try. Basic joint injections can cost about $1,000 and, based on the condition, more specialized procedures can cost up to $ 100,000. In 2020, the average cost of stem cell therapy can range from $4000 - $8,000 in the USA. Therefore, the high cost of cell therapy restraints the growth of the cell therapy market.
Key players in the market are strategically partnering and collaborating to expand the product portfolio and geographical presence of the company. For instance, in April 2018, Eli Lilly, an American pharmaceutical company entered into a collaboration agreement with Sigilon Therapeutics, a biopharmaceutical company that focused on the discovery and development of living therapeutics to develop cell therapies for type 1 diabetes treatment by using the Afibromer technology platform. Similarly, in September 2018, CRISPR Therapeutics, a biotechnological company that develops transformative medicine using a gene-editing platform for serious diseases, and ViaCyte, a California-based regenerative medicine company, collaborated on the discovery, development, and commercialization of allogeneic stem cell therapy for diabetes treatment.
The rising prevalence of chronic diseases contributed to the growth of the cell therapy market. According to the US Centers for Disease Control and Prevention (CDC), chronic disease is a condition that lasts for one year or more and requires medical attention or limits daily activities or both and includes heart disease, cancer, diabetes, and Parkinson's disease. Stem cells can benefit the patients suffering from spinal cord injuries, type 1 diabetes, Parkinson's disease (PD), heart disease, cancer, and osteoarthritis.
According to Cancer Research UK, in 2018, 17 million cancer cases were added to the existing list, and according to the International Diabetes Federation, in 2019, 463 million were living with diabetes. According to the Parkinson's Foundation, every year, 60,000 Americans are diagnosed with PD, and more than 10 million people are living with PD worldwide. The growing prevalence of chronic diseases increased the demand for cell therapies and contributed to the growth of the market.
Key Topics Covered:
1. Executive Summary
2. Cell Therapy Market Characteristics
3. Cell Therapy Market Size And Growth 3.1. Global Cell Therapy Historic Market, 2015 - 2019, $ Billion 3.1.1. Drivers Of The Market 3.1.2. Restraints On The Market 3.2. Global Cell Therapy Forecast Market, 2019 - 2023F, 2025F, 2030F, $ Billion 3.2.1. Drivers Of The Market 3.2.2. Restraints On the Market
4. Cell Therapy Market Segmentation 4.1. Global Cell Therapy Market, Segmentation By Technique, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion
4.2. Global Cell Therapy Market, Segmentation By Therapy Type, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion
4.3. Global Cell Therapy Market, Segmentation By Application, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion
5. Cell Therapy Market Regional And Country Analysis 5.1. Global Cell Therapy Market, Split By Region, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion 5.2. Global Cell Therapy Market, Split By Country, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion
Companies Mentioned
For more information about this report visit https://www.researchandmarkets.com/r/rblnmb
Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.
Media Contact:
Research and Markets Laura Wood, Senior Manager [emailprotected]
For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716
SOURCE Research and Markets
http://www.researchandmarkets.com
See the rest here:
Global Cell Therapy Market Report 2020: Market to Recover in 2023 - PRNewswire
Direct Biologics Announces First Patient Treated Under Phase II Expanded Access Protocol Using ExoFlo(TM) to Treat COVID-19 – Tyler Morning Telegraph
By daniellenierenberg
AUSTIN, Texas, Dec. 30, 2020 /PRNewswire/ --Direct Biologics, LLC, announced today that the first patient has been treated under its expanded access protocol for ExoFlo Infusion Treatment for COVID-19 Associated ARDS (EXIT COVID-19).
"The Phase II trial is actively enrolling patients at several sites nationally. It has met several key milestones and is nearing completion," states Co-Founder and Chief Executive Officer, Mark Adams. "We look forward to sharing our results and hopefully proceeding to Phase III very soon."
The expanded access protocol is an open label study to treat patients who often have more advanced disease under a "compassionate use" application.
"The expanded access gives us an opportunity to treat very sick patients who do not have other meaningful options," notes Joe Schmidt, Co-Founder and President. "It also enhances our ability to treat patients at additional hospitals and therefore communities in need across the country."
Chief Medical Officer, Vik Sengupta, MD, adds, "We at Direct Biologics are grateful for every opportunity to help these additional patients in critical need of treatment."
This study is under the same IND application utilizing bone marrow-derived extracellular vesicles to treat COVID-19-associated ARDS. Extracellular vesicles secreted by bone marrow-derived mesenchymal stem cells (bmMSCs) have been studied extensively in preclinical studies of lung disease and inflammation and are notable for their ability to downregulate inflammation and upregulate tissue repair.
Physicians can learn more at clinicaltrials.gov and may request access for a patient by emailing msl@directbiologics.com. Requests for expanded access to ExoFlo must be made by a licensed U.S. treating physician.
About ExoFlo
ExoFlo is an investigational new drug that has not been approved or licensed by the FDA. It is an extracellular vesicle product isolated from human bone marrow mesenchymal stem or stromal cells (MSCs). ExoFlo provides natural bioactive signals that have been shown to modulate inflammation and direct cellular communication.
About Direct Biologics
Direct Biologics, LLC, is headquartered in Austin, Texas, with a recently expanded R&D facility located at the University of California, and an Operations and Order Fulfillment Center located in St. Louis, Missouri. Direct Biologics is a market-leading innovator and cGMP manufacturer of regenerative medical products, including a robust line of extracellular vesicle-based biological products. The Company was created to expand the science of regenerative healing by delivering cutting-edge biologic technologies. Direct Biologics' management team holds extensive collective experience in biologics research, development, and commercialization, making the Company a leader in the evolving, next-generation segment of the biotherapeutics industry. Direct Biologics is dedicated to pursuing additional clinical applications of its extracellular vesicle biologic products through the FDA's investigational new drug application process. For more information, visithttp://www.directbiologics.com.
Phone:1-800-791-1021Email:info@directbiologics.com
Related Images
direct-biologics-logo.pngDirect Biologics Logo
Follow this link:
Direct Biologics Announces First Patient Treated Under Phase II Expanded Access Protocol Using ExoFlo(TM) to Treat COVID-19 - Tyler Morning Telegraph
Lonza’s Cocoon will soon make dozens of stem cell therapies all at once – Innovation Origins
By daniellenierenberg
The name Lonza comes from the river in Switzerland near where the company was originally founded more than a hundred years ago, As such, it has nothing to do with the biomedical products and services that Lonza provides.
Lonza is active around the world and has around 15,000 employees with branches in the Netherlands as well. Such as the one on the BrightlandsChemelot Campus in Geleen. where approximately 250 people work there. This company division started as a start-up in Maastricht in 2005 and developed a production facility for stem cell and gene therapy to combat diseases. It became part of Lonza in 2018.
The reason that Lonza is on the Chemelot campus is due to its strategic location. This is very convenient for having access to all kinds of industry-related services that are already available there, says Willem Dullaers. He is the senior manager of quality control at Lonza in Geleen. Security is well organized, and we use a number of other facilities so that as a company you dont need to arrange these yourself.
The interesting thing about the Lonza production facility in Geleen is that the company isolates living cells and is even able to manipulate them on behalf of pharmaceutical groups. These companies then supply them to hospitals for the treatment of patients, primarily those suffering from forms of cancer. So what does Lonza do exactly and what does it ultimately deliver to those hospitals? is the question for Dullaers. This is not so easy to explain.
We work in cleanrooms at Lonzas premises in Geleen with the aim of selecting body cells from a sample of the patient taken in the hospital via a blood transfusion or bone marrow puncture. For example, body cells that are selected have the ability to fight cancer cells by virtue of their specific properties. If these cells are selected and reproduce in number after being cultured, it can be useful to add DNA to them so that they are able to attack the cancer cells even more effectively. Modification is done using a piece of deactivated virus that is used as a vector to introduce DNA into the selected cells.
Once that process is completed, the number of cells, which is usually very small, is cultivated to a larger quantity so that after various quality checks and the preparation for transport (cooled or frozen) are carried out, the cells are introduced into the patient. It is very common that patients are successfully treated afterward, says Dullaers. He refers to a report that made the world news last year. An Italian two-year-old boy with a rare immune disease (HLH) who was initially given up by doctors, Alex Montresor, was cured after stem cell therapy.
About 30 people are currently working on the production process for cell and gene therapy to treat people, Dullaers adds. The tasks that the biomedical doctors have to perform take time and require careful attention. They have to enter the cleanroom themselves to put the cells through the process to be transformed into stem cell therapies. They have to wear protective, hermetically sealed suits under the strictest safety conditions. That is to safeguard their own safety but also to prevent any potential contamination of the cells. Patients for whom this therapy is intended are often severely debilitated. They are not allowed to get sick as a result of a bacterium or particulate matter that has entered the cultured cells. A check always takes place to make sure that the product is completely clean. If this is not the case, it must be remade as a last resort.
At the moment, Lonza is working on a method to fully automate the culture process of the cells in the cleanroom. A pilot is currently underway at the Sheba Medical Center in Israel. It has a test setup with a so-called cocoon. The cocoon looks like an egg-shaped module of white plastic that is about one meter long. Inside the egg there is a small factory that automates all operations, from cell selection to DNA insertion and preparation for transport and administration.
Over the coming years, this innovative culture method for cell and gene therapy must be approved through clinical trials and by medicinal regulatory agencies such as the U.S. FDA and the European EMA. Only then can this robotized method be applied on a large scale.
I hope it will be achievable within five to ten years, says Dullaers. That will change a lot in terms of affordability and supply options for cell and gene therapy. Because it is such a cumbersome treatment, the costs are high right now. The production also takes a lot of time. Depending on the complexity of the process, the duration varies from a few days to sometimes more than two months, Dullaers notes.
If the entire process can be robotized, fewer people will be needed to do the work. I think that whereas we now work with 150 people, you will be able to do it with 15. However, you will need a different set of employees: People with a software background and an understanding of the machinery.
You can simultaneously fill a room with dozens of cocoons where cell therapies are made. That means that productivity is bound to skyrocket. Consequently, it will also be possible to make more medication based on the cells of individual patients, which will also be cheaper since less staff is needed. The chance of making mistakes is smaller than with work that involves human hands, Dullaers points out.
Another alternative is for hospital laboratories to make the gene and cell therapies themselves. It is conceivable that they would like to have a cocoon in their own hospital that they can use to treat patients.
You can also read the earlier articles in this series here:
The Chinese and Americans are knocking on the Dutch town of Geleens door to test innovative chem tech
Xilloc: Requests from dozens of hospitals worldwide for 3D-printed implants
Dutch Arlanxeo: 85% less CO2 emissions thanks to rubber from sugar cane
Niaga: 100% recyclable mattresses, furniture and carpets have the future
Visit link:
Lonza's Cocoon will soon make dozens of stem cell therapies all at once - Innovation Origins
Bone Marrow Processing Systems Market to Make Great Impact in near Future by -2025 – The Monitor
By daniellenierenberg
Bone marrow aspiration and trephine biopsy are usually performed on the back of the hipbone, or posterior iliac crest. An aspirate can also be obtained from the sternum (breastbone). For the sternal aspirate, the patient lies on their back, with a pillow under the shoulder to raise the chest. A trephine biopsy should never be performed on the sternum, due to the risk of injury to blood vessels, lungs or the heart.
More insightful information | Request a sample copy @https://www.trendsmarketresearch.com/report/sample/3374
The need to selectively isolate and concentrate selective cells, such as mononuclear cells, allogeneic cancer cells, T cells and others, is driving the market. Over 30,000 bone marrow transplants occur every year. The explosive growth of stem cells therapies represents the largest growth opportunity for bone marrow processing systems.
Europe and North America spearheaded the market as of 2018, by contributing over 74.0% to the overall revenue. Majority of stem cell transplants are conducted in Europe, and it is one of the major factors contributing to the lucrative share in the cell harvesting system market.
In 2018, North America dominated the research landscape as more than 54.0% of stem cell clinical trials were conducted in this region. The region also accounts for the second largest number of stem cell transplantation, which is further driving the demand for harvesting in the region.
Do you have any questions or specific requirements for Report ? Ask industry experts @https://www.trendsmarketresearch.com/checkout/3374/Single
Asia Pacific is anticipated to witness lucrative growth over the forecast period, owing to rising incidence of chronic diseases and increasing demand for stem cell transplantation along with stem cell-based therapy. Japan and China are the biggest markets for harvesting systems in Asia Pacific. Emerging countries such as Mexico, South Korea, and South Africa are also expected to report lucrative growth over the forecast period. Growing investment by government bodies on stem cell-based research and increase in aging population can be attributed to the increasing demand for these therapies in these countries.
Major players operating in the global bone marrow processing systems market are ThermoGenesis (Cesca Therapeutics inc.), RegenMed Systems Inc., MK Alliance Inc., Fresenius Kabi AG, Harvest Technologies (Terumo BCT), Arthrex, Inc. and others.
Talk to our Analyst / Ask for a discount on Market and Get More Information Related to This Report@https://www.trendsmarketresearch.com/report/discount/3374
Go here to read the rest:
Bone Marrow Processing Systems Market to Make Great Impact in near Future by -2025 - The Monitor
The Myeloproliferative Disorders Drugs Market to grow on an exceptional note in the next 10 years – LionLowdown
By daniellenierenberg
Myeloproliferative disorders are disease of blood and bone marrow which have unknown cause and there are wide range of symptoms. The treatment of myeloproliferative disorders generally depends on the type and presence of symptoms. Myeloproliferative disorders is generally considered as clonal disorder which begins with one or more change in the DNA of a single stem cells in the bone marrow. The changes to the hematopoietic stem cell cause the cell to reproduce repeatedly, creating more abnormal stem cells and these abnormal cells become one or more types of blood cells. Myeloproliferative disorders gets worst with time as the number of extra blood cells build up in the bone marrow and bloodstream.
To remain ahead of your competitors, request for a sample[emailprotected]https://www.persistencemarketresearch.com/samples/27949
Emergence of new treatment for the myeloproliferative disorders and availability of novel drug drive the market for myeloproliferative disorders drugs market in the near future. Rising incidence of myeloproliferative disorders and presence of strong product pipeline spur the myeloproliferative disorders drugs market. Growing geriatric population, change in lifestyle and growing awareness among general population is expected to drive the market of myeloproliferative disorders in the forecast period. Advancement in the treatment for oncology further expand the treatment option for myeloproliferative disorders. Various clinical trial undergoing for the treatment of myeloproliferative disorders which further drive the growth of the myeloproliferative disorders drugs market. However, high cost of drug and treatment along with the lack of awareness among the population in developing and under developed nations hinder the growth of myeloproliferative disorders drugs market.
The global myeloproliferative disorders drugs market is segmented on basis of Type, Drug Type, Distribution Channel, End User and Geography.
To receive Methodology request here @https://www.persistencemarketresearch.com/methodology/27949
Improvement in the symptoms and reduction of in splenomegaly among patients receiving available therapy is expected to boost the market of myeloproliferative disorders. Development in new therapeutic drug and target therapy further drive the market growth of myeloproliferative disorders. Increased research and development and increased funding by the government towards the development of novel therapy spur the market growth. With the discovery of specific gene mutations in myeloproliferative disorders the market is expected to grow in the forecast period owing to increased adoption of new drugs and increased awareness along with the favorable reimbursement scenarios for the treatment of myeloproliferative disorders.
The North America market holds the largest revenue share for myeloproliferative disorders drugs, due to presence of major pharmaceutical players undergoing various clinical innovation, government initiative and increase research and development funding for the Myeloproliferative disorders. Europe is expected to contribute for the second largest revenue share after North America in the global myeloproliferative disorders drugs market, owing to merging treatment option and development of oncology drug discovery and rising prevalence of myeloproliferative disorders. Asia Pacific is expected to show rapid growth, due to increasing number of vascular surgeons and low cost of peripheral interventions. China is expected to register fast growth, due to significant increase in the number of innovative firm and research organization and increasing importance of pharmaceutical research & development activities and investments in research for developing new drugs. Latin America and Middle East & Africa are projected to exhibit sluggish growth in myeloproliferative disorders Drugs market, due to proper healthcare systems and adoption of new drug and therapy.
To receive extensive list of important regions, Request TOC here @https://www.persistencemarketresearch.com/toc/27949
Examples of some of the key manufacturer present in the global myeloproliferative disorders drugs market are
Explore Extensive Coverage of PMR`sLife Sciences & Transformational HealthLandscape
Persistence Market Research (PMR) is a third-platform research firm. Our research model is a unique collaboration of data analytics andmarket research methodologyto help businesses achieve optimal performance.
To support companies in overcoming complex business challenges, we follow a multi-disciplinary approach. At PMR, we unite various data streams from multi-dimensional sources. By deploying real-time data collection, big data, and customer experience analytics, we deliver business intelligence for organizations of all sizes.
Our client success stories feature a range of clients from Fortune 500 companies to fast-growing startups. PMRs collaborative environment is committed to building industry-specific solutions by transforming data from multiple streams into a strategic asset.
Contact us:
Naved BegPersistence Market ResearchAddress 305 Broadway, 7th Floor New York City,NY 10007 United StatesU.S. Ph. +1-646-568-7751USA-Canada Toll-free +1 800-961-0353Sales[emailprotected]Websitehttps://www.persistencemarketresearch.com
Read the rest here:
The Myeloproliferative Disorders Drugs Market to grow on an exceptional note in the next 10 years - LionLowdown
2020: The year science took centre-stage – The Hindu
By daniellenierenberg
Apart from new findings on coronavirus every single day, the year was also filled with stories from outer space, archeology and anatomy
The year 2020 also termed as the year of the pandemic, social distancing, work from home, was also the year of research at breakneck speed. Virologists, immunologists, computational biologists, epidemiologists, and medical professionals across the globe turned into superheroes without capes.
Quick sequencing of the whole genome of the novel coronavirus (SARS-CoV-2) helped develop various test kits. We now have not one or two, but multiple COVID-19 vaccines that have succeeded in human clinical trials. Moderna's and Pfizer-BioNTechs vaccines that use messenger RNA have reported efficacy of about 95%, and the United Kingdom, the United States and the United Arab Emirates have already launched mass vaccinations.
Apart from new findings on coronavirus every single day, the year was also filled with stories from outer space, archeology and anatomy. Here is a list of a few of them in random order
In October, NASA confirmed, for the first time, water on the sunlit side of the Moon indicating that water may be distributed across the moons surface, and not limited to the cold and shadowed side.
Researchers from the Netherlands Cancer Institute announced in October that they have discovered a new pair of salivary glands hidden between the nasal cavity and throat. The team proposed the name tubarial glands and noted that this identification could help to explain and avoid radiation-induced side-effects such as trouble during eating, swallowing, and speaking.
In September, an international scientific team announced that they have spotted phosphine gas on Venus. On Earth, microorganisms that live in anaerobic (with no oxygen) environments produce phosphine. Massachusetts Institute of Technology molecular astrophysicist and study co-author Clara Sousa-Silva said in a release, This is important because, if it is phosphine, and if it is life, it means that we are not alone. It also means that life itself must be very common, and there must be many other inhabited planets throughout our galaxy.
Read our detailed explainer here.
In March, a person suffering from Leber congenital amaurosis, a rare inherited disease that leads to blindness, became the first to have CRISPR/Cas-9-based therapy directly injected into the body.
In June, two patients with beta-thalassemia and one with sickle cell disease had their bone marrow stem cells edited using CRISPR techniques.
Click here to read our explainer on the genome-editing tool that won this years Nobel Prize for Chemistry.
The year 2020 marks 100 years of discovery of Indus Valley Civilisation, and a new study showed that dairy products were being produced by the Harappans as far back as 2500 BCE.
Another study found the presence of animal products, including cattle and buffalo meat, in ceramic vessels dating back about 4,600 years.
Chinas Change-5 probe brought back about 1,731 grams of samples from the moon becoming the third country to bring moon samples after the U.S and Soviet Union.
Also, Japans Hayabusa 2 brought back the first extensive samples from an asteroid. The spacecraft, launched from Japan's Tanegashima space centre in 2014, took four years to reach the asteroid Ryugu before taking a sample and heading back to Earth in November 2019.
Mars rover Perseverance blasted off for the red planet on July 30 to bring the first Martian rock samples back to Earth. If all goes well, the rover will descend to the Martian surface on February 18, 2021.
You have reached your limit for free articles this month.
Find mobile-friendly version of articles from the day's newspaper in one easy-to-read list.
Enjoy reading as many articles as you wish without any limitations.
A select list of articles that match your interests and tastes.
Move smoothly between articles as our pages load instantly.
A one-stop-shop for seeing the latest updates, and managing your preferences.
We brief you on the latest and most important developments, three times a day.
Support Quality Journalism.
*Our Digital Subscription plans do not currently include the e-paper, crossword and print.
Read the original here:
2020: The year science took centre-stage - The Hindu
The Complete Guide to Laser Treatments for Hair and Skin | The Science of Beauty Podcast | Allure – Allure
By daniellenierenberg
More than 25 years ago, it was a patient with a port-wine stain who inspired Alster to learn more about the then-fledgling world of lasers. Alster accepted a fellowship in Boston, where her patient traveled to receive treatments. So in essence, I changed her life because I significantly lightened the birthmark to the point where she didn't need to cover it, says Alster. And she changed my life because I wouldn't have looked into lasers if it wasn't for her... I ended up opening up my own center in Washington, D.C. in 1990. And at that time it was the only freestanding laser center in the world.
Lasers and Scars
Lasers can treat many types of scars, including surgical scars, acne scars, and scars from injuries. They penetrate the epidermis to stimulate new, healthy skin cell growth. The most common lasers used in scar removal are ablative fractional carbon dioxide lasers, Nd:YAG, nonablative fractional lasers, and pulsed dye lasers.
Lasers and Hair Removal
Laser hair removal is a medical procedure that uses a concentrated beam of light to remove unwanted hair. The laser emits a light that is absorbed by the pigment (melanin) in the hair. The light energy is converted to heat, which then damages the hair follicles that produce hairs. This damage inhibits or delays future hair growth. With repeated treatments, laser hair removal can permanently reduce unwanted hair. While all hairs dont fall out immediately, they will shed within days to weeks of treatment.
But lasers arent only used for hair reduction. Low-Level Laser Therapy (LLLT) is a relatively new treatment that uses low-power lasers to stimulate hair growth. Its hypothesized that LLLT stimulates stem cells in the hair follicle and shifts the follicles in the anagen (growth) stage of the hair cycle.
How is LED different from lasers?
Commonly confused with lasers, light-emitting diodes (LED) can reduce fine lines, increase collagen production, and smooth skin by using varying color wavelengths of visible LED light. Lasers, on the other hand, often use a single wavelength, and the beam is ideal for stimulating changes that only respond to very specific wavelengths (hair removal, dark spot removal, etc.).
Can you combine lasers with other in-office treatments in the same session?
Short answer: Yes! Depending on the laser you and your dermatologist choose, you can get filler or Botox in the same treatment. Some experts will specifically recommend injectables with Fraxel within the same appointment since its considered safe and delivers a rather dramatic final result. Alster often combines non-ablative laser treatments with microneedling to amplify the effects.
Can you be too young for lasers?
When deciding whether or not to try a laser, your age shouldnt be a major deciding factor. It's more of a matter of the problem you want to fix, not how old you are. Many young people have rosacea, acne, sun spots, and sun damage all of which are treatable with lasers. Still, less-intensive therapies, such as chemical peels, are likely enough to repair young, relatively healthy skin (and are often less expensive).
Is it safe to laser your skin at home?
There are various options for at-home laser treatments that you can use safely. Typically, at-home devices have significantly lower power than those used in a medical setting, in order to reduce risks. Many lasers for wrinkles or acne are simply LED light products, like the Dr. Dennis Gross Skincare DRx SpectraLite mask. There are, however, a few at-home non-ablative fractional lasers available, like the Tria SmoothBeauty Laser.
Michelles Current Favorites
While everyones skin is different and your personal dermatologist knows whats best for you Michelle says she slathered her face with Aquaphor following a Fraxel treatment. You really do need to keep your skin moist [afterward], she says. And then it's all about sunscreen, sunscreen, sunscreen. Right now, Michelle is into Dr. Loretta Urban Antioxidant Sunscreen SPF 40, which has a slight tint.
Jennys Current Favorites
Like Michelle, Jenny used Aquaphor after getting Fraxel. She also used CeraVe Moisturizing Cream post-treatment to help speed up healing. And in order to cover up the sandpaper-like texture and small, dark dots that often arise after getting Fraxel, Jenny used Oxygenetix Oxygenating Foundation. A lot of dermatologists and plastic surgeons recommend it for people to use this when they're healing, she says. It's thicker than what I would normally use for foundation, but it gave a really seamless finish [and] got me through that week or two after [treatment].
Like many in-office treatments, lasers often come with some downtime. But good things come to those who wait: Lasers can have a huge impact on the look and health of your skin.
Original post:
The Complete Guide to Laser Treatments for Hair and Skin | The Science of Beauty Podcast | Allure - Allure
The big scientific breakthroughs of 2020 – The Week
By daniellenierenberg
Sign Up for
Our free email newsletters
Vaccines at warp speed
Only one breakthrough truly mattered this year: the creation of a COVID-19 shot. The previous record for the fastest vaccine development, for mumps, was four years. But on Dec. 8 11 months after research began a 90-year-old British grandmother became the first person in the world to receive Pfizer's new COVID vaccine outside of a clinical study. Like Moderna's new shot, which was approved in the U.S. last week, the two-dose vaccine is about 95 percent effective and uses an entirely new type of technology. In traditional vaccines, a patient is injected with dead viral material, which triggers the body to produce antibodies. Pfizer's and Moderna's shot use a synthetic version of coronavirus genetic material that leads human cells to produce copies of the virus' outer spike proteins. Those proteins spark an immune defense. Pfizer and Moderna together hope to deliver enough doses for 20 million people by Dec. 31. "The light at the end of the tunnel is getting a little brighter," says infectious-disease expert Dr. William Schaffner.
Solving a protein puzzle
An artificial intelligence program appears to have solved one of the biggest mysteries in biology. The "protein-folding problem" is important because most biological processes such as how insulin controls blood-sugar levels or how antibodies fight coronaviruses are driven by proteins. How the strings of amino acids that make up a protein twist and fold into a 3D shape determines its function. Trying to establish how proteins get their origami-like structure can take years of lab work. But AlphaFold, an artificial intelligence program developed by the Google-owned DeepMind lab, can do it in a matter of hours with a remarkable level of accuracy. Bioinformatics professor Janet Thornton says protein-folding was "a problem that I was beginning to think would not get solved in my lifetime."
Building living 'bots
American scientists have created the world's first living robots. The millimeter-wide "xenobots" were formed by scraping live stem cells from frog embryos and leaving them to incubate. The resulting skin and heart cells were then reshaped and combined into "body forms" designed by a supercomputer to complete certain tasks walking, for example, or swimming. The pulsing heart cells serve as a miniature engine that powers xenobots until their energy reserves run out after about 10 days at present. Study co-leader Michael Levin says these "living, programmable organisms" might one day carry out tasks such as removing plaque from artery walls.
Signs of life on Venus?
Scientists have found hints that life might exist on Venus a notoriously inhospitable planet where surface temperatures hit 860 degrees Fahrenheit. Using powerful telescopes, researchers detected traces of the gas phosphine in the Venusian atmosphere. On Earth, that gas is produced by human industry and by microbial organisms that live in oxygen-free environments. Phosphine is quick to react and disappear, so something must be replenishing its supply on Venus. Researchers say it's not implausible that single-celled life might survive in the Venusian atmosphere, floating in a region where liquid water exists. Study co-author Sara Seager says the only way to confirm this theory is by "actually going to Venus."
This article was first published in the latest issue of The Week magazine. If you want to read more like it, you can try six risk-free issues of the magazine here.
Stem Cell Therapy Market Estimated to Expand at a Robust CAGR over 2025 – The Monitor
By daniellenierenberg
Of late, there has been an increasing awareness regarding the therapeutic potential of stem cells for management of diseases which is boosting the growth of the stem cell therapy market. The development of advanced genome based cell analysis techniques, identification of new stem cell lines, increasing investments in research and development as well as infrastructure development for the processing and banking of stem cell are encouraging the growth of the global stem cell therapy market.
Get Exclusive PDF Sample Copy Of This Report:https://www.tmrresearch.com/sample/sample?flag=B&rep_id=1787
One of the key factors boosting the growth of this market is the limitations of traditional organ transplantation such as the risk of infection, rejection, and immunosuppression risk. Another drawback of conventional organ transplantation is that doctors have to depend on organ donors completely. All these issues can be eliminated, by the application of stem cell therapy. Another factor which is helping the growth in this market is the growing pipeline and development of drugs for emerging applications. Increased research studies aiming to widen the scope of stem cell will also fuel the growth of the market. Scientists are constantly engaged in trying to find out novel methods for creating human stem cells in response to the growing demand for stem cell production to be used for disease management.
It is estimated that the dermatology application will contribute significantly the growth of the global stem cell therapy market. This is because stem cell therapy can help decrease the after effects of general treatments for burns such as infections, scars, and adhesion. The increasing number of patients suffering from diabetes and growing cases of trauma surgery will fuel the adoption of stem cell therapy in the dermatology segment.
Global Stem Cell Therapy Market: Overview
Also called regenerative medicine, stem cell therapy encourages the reparative response of damaged, diseased, or dysfunctional tissue via the use of stem cells and their derivatives. Replacing the practice of organ transplantations, stem cell therapies have eliminated the dependence on availability of donors. Bone marrow transplant is perhaps the most commonly employed stem cell therapy.
Osteoarthritis, cerebral palsy, heart failure, multiple sclerosis and even hearing loss could be treated using stem cell therapies. Doctors have successfully performed stem cell transplants that significantly aid patients fight cancers such as leukemia and other blood-related diseases.
Buy This Report @https://www.tmrresearch.com/checkout?rep_id=1787<ype=S
Global Stem Cell Therapy Market: Key Trends
The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.
On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.
Global Stem Cell Therapy Market: Market Potential
A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.
In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.
Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.
Global Stem Cell Therapy Market: Regional Outlook
The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.
Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.
Global Stem Cell Therapy Market: Competitive Analysis
Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.
Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.
To know more about the table of contents, you can click @https://www.tmrresearch.com/sample/sample?flag=T&rep_id=1787
About TMR Research
TMR Research is a premier provider of customized market research and consulting services to busi-ness entities keen on succeeding in todays supercharged economic climate. Armed with an experi-enced, dedicated, and dynamic team of analysts, we are redefining the way our clients conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.
View post:
Stem Cell Therapy Market Estimated to Expand at a Robust CAGR over 2025 - The Monitor
Stem cells from cord blood can now be used across many conditions: Mayur Abhaya, MD & CEO, LifeCell Internat.. – ETHealthworld.com
By daniellenierenberg
Shahid Akhter, editor, ETHealthworld, spoke to Mayur Abhaya, MD & CEO, LifeCell International, to know more about the latest advancements in Stem cell industry and how it has recovered from the Covid challenges.Impact and challenges of Covid-19 on the Stem cell industry ?One of the biggest issues faced by the stem cell industry during the pandemic was the transport of the cells after collection at birth. It needs to reach the lab within 72 hours and in the case of bone marrow stem cell from donation all the way until it reaches the patient that also has to be completed within 72 hours. The bone marrow cells cannot be handed over in courier. It has to be manually hand carried and that created a huge logistics hurdle were transplants significantly reduced in numbers because of the availability of donors and the transport issues around it.
What are the current global trends in the Stem Cell Industry at large?The recent clinical progress that has been made in the medical space of stem cell transplantation is that now cord blood is considered as a better source than bone marrow cells. This was found in a research study based in US, published in 2020. They have also shown that stem cells from the cord blood can now be used across many conditions with the same treatment protocol. Besides that, the preparation of the patient is different in different conditions but now they have simplified that and reduced the risk of death to a very, very low number. So the cord blood is preferred, as the outcomes are improving.How has Life Cell managed the scenario during the pandemic? Do let us know your challenges and the way forward plan?One of the biggest issues during the pandemic was transport, especially the flight operations because we heavily depend on them for moving the samples across the country. We had to revert to an alternate plan where we had to transport these samples through a relay network from one city to another, through a road network. Luckily LifeCell has operations across the country covering more than 250 cities. So still we had the ability to ensure that our commitment of getting the samples to the lab within those 72 hours was very much possible.
Another major milestone during this pandemic that we were able to help was to support a transplant were a child having Aplastic Anaemia needed not one but two cord blood units for the transplant and within the family they couldnt find a match. Luckily because of the LifeCell network and the inventory size of 50,000 units we were able to meet the requirements of the transplant and happy to share the outcome was very successful. So LifeCell ensures that we have appropriate training for its paramedical staff and they are also provided with the appropriate personal protective gears. There are restrictions on the entry of the team inside during the collection we work with the medical staff in the collection rooms, in the operation theatres to ensure a smooth and a well organised collection and even at the lab we have protocols that ensures hygiene and safety within the team and, the operating rooms we have for processing are also well managed.
Your future plans to ensure the smooth collection of Cord Blood?To ensure business continuity we have our teams located very close to our lab itself, you know, so about 100+ member team are placed within a Kilometer of the operating facility. We have adequate stocks, lots of the testing and the processing, consumables that we use are imported. We, at least, maintain 3 month inventory. We also have onsite power back up systems which include a month of diesel supply, month of liquid nitrogen supply and the teams also have a plan that we have a back site also with arrangements done. If for any reason we have cut off of the Chennai centre we have arrangements with an alternate lab to ensure the continuity of the operations
See original here:
Stem cells from cord blood can now be used across many conditions: Mayur Abhaya, MD & CEO, LifeCell Internat.. - ETHealthworld.com
‘We had to take our health into our hands’ – Meet the siblings fighting for their lives with sickle cell disease – South West Londoner
By daniellenierenberg
Siblings Nabila Nakigozi and Fauzan Ssebaggala were diagnosed with sickle cell disease at birth, and with time running out they are taking action.
20-year old Nabila was also diagnosed with avascular necrosis the collapse of bones and as a result is losing her left hip.
She said: Sickle cell is very unpredictable. You can go from happy, to in pain and crying in a matter of minutes. Pain has stolen my childhood and now my adulthood.
Sickle cell disease (SCD) is a group of inherited red blood cell disorders. Those with SCD red blood cells are crescent or sickle shape. This can block blood flow through the body and can lead to many health problems including strokes and episodes of pain.
Fauzan, 24, is now disabled also due to avascular necrosis which has led to the collapse of his spine and hips.
He said: I spent last night crying in pain, every breath I take is painful.
There are two known cures for sickle cell, bone marrow and stem cell transplants.
After extensive research, the siblings have located a private doctor in India who specialises in sickle cell and are fundraising for the expensive but life- saving bone marrow transplant.
Nabila said: Discussions about this procedure is what should be happening within the NHS. We have waited for action but there is always an excuse.
On 11 November, The Parliaments Joint Committee released a report titled Black People, Racism and Human Rights.
The report found that more than 60% of Black people in the UK do not believe their health is as equally protected by the NHS compared to white people.
SCD commonly affects people of African and Caribbean descent.
Fauzan said: The NHS as a whole needs to re-evaluate its position on sickle cell because they can be very insensitive towards us.
There are assumptions that we are not really in pain and just addicted to morphine.
For Nabila, going through this with her brother makes every day easier.
She said: It might sound odd, but its probably the best thing that could have happened to both of us. We lean on each other for support.
But for Fauzan, seeing his sister suffer is difficult to watch.
He said: As an older brother, Im meant to be looking after her. Its heart-breaking knowing there are things I cant do for her.
Nabila is in hospital 80% of the time. I struggle looking into her eyes and confidently saying, tomorrow will be fine.
The east London duo are passionate about highlighting the pain those with SCD go through beyond the surface.
Nabila said: We were born in Uganda and within the African community it isnt always acknowledged that the disease affects us mentally too.
Fauzan added: Ive really struggled with my mental health, and I felt a lot of pressure as a result of not working.
Despite their struggles, the siblings hope to be a voice for those with SCD through their charitable fashion brand, Werent Born Rich.
They make streetwear clothing, with a portion of the profits going to sickle cell patients.
Nabila said: I want people to look at Werent Born Rich and be inspired. If I can be this sick and continue to fight, so can you.
Tracy Williams, project manager for blood donation at the Sickle Cell Society, has advocated through multiple projects for more Black and mixed heritage blood donors.
She manages two projects South London Gives and Give Blood, Spread Love.
Tracy said: Only 1% of people who give blood are of Black heritage. This number needs to increase to help those with sickle cell with Exchange Blood Transfusions.
We advocate for the patient voice, and of that of families affected by SCD. Our goal is to improve the overall wellbeing for people with sickle cell by accessing excellent treatment, mental health support and easily accessible ethnically matched blood.
Despite SCD being the fastest growing genetically inherited condition in the UK, research remains limited.
She said: We have seen positive changes however we would like to see more research for widely accessible treatments. We also continue to campaign for their exemption from prescription charges.
Williams message for the Black community is clear.
She said: Your blood is needed. Donating blood is safe and the process takes half an hour. Its your chance to literally save someones life.
If you are not from our target communities be an ally and share our message too.
Vape Flavorings Are Cardiotoxic and Can Damage the Heart – SciTechDaily
By daniellenierenberg
The vape flavorings so popular with kids and young adults are cardiotoxic and disrupt the hearts normal electrical activity, a University of South Florida Health preclinical study finds.
The appealing array of fruit and candy flavors that entice millions of young people take up vaping can harm their hearts, a preclinical study by University of South Florida Health (USF Health) researchers found.
Mounting studies indicate that the nicotine and other chemicals delivered by vaping, while generally less toxic than conventional cigarettes, can damage the lungs and heart. But so far there has been no clear understanding about what happens when the vaporized flavoring molecules in flavored vaping products, after being inhaled, enter the bloodstream and reach the heart, said the studys principal investigator Sami Noujaim, PhD, an associate professor of molecular pharmacology and physiology at the USF Health Morsani College of Medicine.
In their study published on November 20, 2020, in the American Journal of Physiology- Heart and Circulatory Physiology, Dr. Noujaim and colleagues report on a series of experiments assessing the toxicity of vape flavorings in cardiac cells and in young mice.
The flavored electronic nicotine delivery systems widely popular among teens and young adults are not harm-free, Dr. Noujaim said. Altogether, our findings in the cells and mice indicate that vaping does interfere with the normal functioning of the heart and can potentially lead to cardiac rhythm disturbances.
Dr. Noujaims laboratory is among the first beginning to investigate the potential cardiotoxic effects of the many flavoring chemicals added to the e-liquids in electronic nicotine delivery systems, or ENDS. He recently received a five-year, $2.2-million grant from the NIHs National Institute of Environmental Health Sciences to carry out this laboratory research. Commonly called e-cigarettes, ENDS include different products such as vape pens, mods, and pods.
Sami Noujaim, PhD, associate professor of molecular pharmacology and physiology at the University of South Florida Health (USF Health) Morsani College of Medicine, has begun investigating preclinically the potential cardiotoxic effects of many flavoring chemicals added to the e-liquids in electronic nicotine delivery systems. Credit: Photo courtesy of USF Health
Vaping involves inhaling an aerosol created by heating an e-liquid containing nicotine, solvents such as propylene glycol and vegetable glycerin, and flavorings. The vaping devices battery-powered heat converts this e-liquid into a smoke-like aerosolized mixture (e-vapor). Manufacturers tout e-cigarettes as a tool to help quit smoking, but evidence of their effectiveness for smoking cessation is limited, and they are not FDA approved for this use. E-cigarettes contain the same highly addictive nicotine found in tobacco products, yet many teens and young adults assume they are safe.
Among the USF Health study key findings:
Whether the mouse findings will translate to people is unknown. Dr. Noujaim emphasizes that more preclinical and human studies are needed to further determine the safety profile of flavored ENDS and their long-term health effects.
A partial government ban on flavored e-cigarettes aimed at stopping young people from vaping focused on enforcement against flavored e-cigarettes with pre-filled cartridges, like those produced by industry leader JUUL. However, teens quickly switched to newer disposable e-cigarettes still sold in a staggering assortment of youth-appealing fruity and dessert-like flavors.
Our research matters because regulation of the vaping industry is a work in progress, Dr. Noujaim said. The FDA needs input from the scientific community about all the possible risks of vaping in order to effectively regulate electronic nicotine delivery systems and protect the publics health. At USF Health, in particular, we will continue to examine how vaping may adversely affect cardiac health.
In 2020, 3.6 million U.S. youths still used e-cigarettes, and among current users, more than eight in 10 reported using flavored varieties, according to the Centers for Disease Control and Prevention.
Reference: In Vitro and In Vivo Cardiac Toxicity of Flavored Electronic Nicotine Delivery Systems by Obada Abou-Assali, Mengmeng Chang, Bojjibabu Chidipi, Jose L. Martinez-de-Juan, Michelle Reiser, Manasa Kanithi, Ravi Soni, Thomas Vincent McDonald, Bengt Herweg, Javier Saiz, Laurent Calcul and Sami F. Noujaim, 20 November 2020, American Journal of Physiology-Heart and Circulatory Physiology.DOI: 10.1152/ajpheart.00283.2020
More:
Vape Flavorings Are Cardiotoxic and Can Damage the Heart - SciTechDaily
Nociceptive neurons shown to boost hematopoiesis | 2020-12-28 – BioWorld Online
By daniellenierenberg
A U.S. study has shown for the first time that enhancing signals from the nociceptive nervous system could provide new approaches to improve the collection of hematopoietic stem cells (HSCs) for treating cancers of the blood and bone marrow, the authors reported in the December 23, 2020, edition of Nature.
The findings may help cancer treatments, as "in a meaningful fraction of leukemia, multiple myeloma and lymphoma patients, particularly those who have received anticancer treatment, the HSC mobilization yield can be insufficient," said study leader Paul Frenette.
"Therefore, more efficient HSC mobilization methods would allow the harvest of sufficient HSCs for life-saving transplantation," said Frenette, a professor and director of the Ruth L. and David S. Gottesman Institute for Stem Cell and Regenerative Medicine Research at Albert Einstein College of Medicine in New York.
HSCs characteristically migrate to different hematopoietic sites during embryonic development and continue to be released from the adult bone marrow.
Most hematopoiesis occurs in the bone marrow, where different types of blood cells are derived from limited numbers of HSCs, which are multipotent and capable of extensive renewal.
The HSC migratory properties have facilitated their collection from the blood and transplantation as regenerative cancer treatment, although the mechanisms by which HSCs migrate out of the bone marrow remain largely unknown.
In tissues exposed to the external environment, such as the skin, lung and gut, nociceptors enable the rapid detection of external insults, including pain, cold or heat, in order to avoid organ damage.
Nociceptor sensory neurons detect these harmful stimuli and can regulate the immune response to them by releasing neurotransmitters and other regulatory molecules.
However, other than for pain perception, the role of nociceptors in a deep tissue, such as the bone marrow, is poorly understood.
In bone marrow, HSCs are found in specialized microenvironments or niches, which are complex regulatory environments influenced by multiple cellular constituents, including nerves.
Although sympathetic nerves are known to regulate the HSC niche, the role of nociceptive neurons in the bone marrow in this regard remains unclear.
"We have previously shown that nerves from the sympathetic nervous system promoted HSC mobilization in bone marrow, so we were curious to see whether nociceptive neurons might also be involved," Frenette told BioWorld Science.
In their new Nature study, the Frenette and his team showed that nociceptive neurons are required for HSC mobilization and that they interact with sympathetic nerves to maintain HSCs in the bone marrow.
Notably, nociceptor neurons were demonstrated to drive granulocyte colony-stimulating factor (G-CSF)-induced HSC mobilization via secretion of calcitonin gene-related peptide (CGRP).
"Our findings may lead to more efficient mobilization methods in [blood and bone marrow cancer] patients in whom existing methods are insufficient," Frenette said.
For example, "we have shown that the CGRP pathway synergizes with G-CSF and plerixafor [(Mozobil, Genzyme), an immunostimulant used to mobilize HSCs into the bloodstream in cancer patients]." Unlike sympathetic nerves, which regulate HSCs indirectly via the bone marrow niche, CGRP was shown to act directly on HSCs via receptor activity modifying protein 1 (RAMP1) and the calcitonin receptor-like receptor to promote HSC egress via Galphas/adenyl cyclase/cAMP signaling pathway activation.
This research identifies potential treatment targets for boosting HSC mobilization, since "we have shown that increasing the downstream signaling of the CGRP receptor RAMP1, by increasing cyclic AMP can enhance HSC mobilization," said Frenette.
Importantly, the Einstein researchers then showed that ingestion of food containing capsaicin, a natural component of chili peppers that can trigger the activation of nociceptive neurons, significantly enhanced HSC mobilization in mice.
"Capsaicin tablets are currently sold over-the-counter to 'help support cardiovascular and digestive function' at higher doses than that predicted by our studies in mice for stimulating HSC mobilization in humans," said Frenette.
"These relatively low concentrations of capsaicin have biological effects without seemingly causing obvious pain," he said.
Collectively, these findings therefore suggest that targeting the nociceptive nervous system could represent a novel strategy by which to improve the yield of HSCs for stem cell-based therapies. (Gao, X. et al. Nature 2020, Advanced publication).
See the rest here:
Nociceptive neurons shown to boost hematopoiesis | 2020-12-28 - BioWorld Online
New class of drugs to treat blood and bone marrow cancers: Research – Hindustan Times
By daniellenierenberg
A group of scientists in the US, including an Indian-American from the prestigious Cleveland Clinic, have identified a potential new class of drugs that may prove effective in treating certain common types of blood and bone marrow cancers.
First published in the latest edition of Blood Cancer Discovery, the decade long research which reports that a new pharmacological strategy to preferentially target and eliminate leukemia cells with TET2 mutations, was carried out by Jaroslaw Maciejewski and his collaborator Babal Kant Jha from the Cleveland Clinic Department of Translational Hematology & Oncology Research.
Myeloid leukemias are cancers derived from stem and progenitor cells in the bone marrow that give rise to all normal blood cells.
One of the most common mutations involved in driving myeloid leukemias are found in the TET2 gene, which has been investigated for the last decade by Maciejewski and Jha.
In preclinical models, we found that a synthetic molecule called TETi76 was able to target and kill the mutant cancer cells both in the early phases of disease--what we call clonal hematopoiesis of indeterminate potential, or CHIP--and in fully developed TET2 mutant myeloid leukemia, said Dr Maciejewski.
According to a media release, the research team designed TETi76 to replicate and amplify the effects of a natural molecule called 2HG (2-hydroxyglutarate), which inhibits the enzymatic activity of TET genes.
The TET DNA dioxygenase gene family codes for enzymes that remove chemical groups from DNA molecules, which ultimately changes what genes are expressed and can contribute to the development and spread of disease.
While all members of the TET family are dioxygenases, the most powerful enzymatic activity belongs to TET2, the press release said.
Even when TET2 is mutated, however, its related genes TET1 and TET3 provide residual enzymatic activity. While significantly less, this activity is still enough to facilitate the spread of mutated cancer cells.
Maciejewskis and Jhas new pharmacologic strategy to selectively eliminate TET2 mutant leukemia cells centers on targeting their reliance on this residual DNA dioxygenase activity, it said.
We took lessons from the natural biological capabilities of 2HG, explained Jha, a principal investigator.
We studied the molecule and rationally designed a novel small molecule, synthesized by our chemistry group headed by James Phillips, PhD. Together, we generated TETi76a similar, but more potent version capable of inhibiting not just TET2, but also the remaining disease-driving enzymatic activity of TET1 and TET3, Jha said.
Cleveland Clinic said that the researchers studied TETi76s effects in both preclinical disease and xenograft models (where human cancer cells are implanted into preclinical models). Additional studies will be critical to investigate the small molecules cancer-fighting capabilities in patients.
We are optimistic about our results, which show not just that TETi76 preferentially restricts the growth and spread of cells with TET2 mutations, but also gives survival advantage to normal stem and progenitor cells, Jha said.
(This story has been published from a wire agency feed without modifications to the text.)
Follow more stories on Facebook and Twitter
Read more here:
New class of drugs to treat blood and bone marrow cancers: Research - Hindustan Times
He got his cheek swabbed at 24. Nothing happened for 14 years. – Las Vegas Review-Journal
By daniellenierenberg
Cade Cridland thought a lot about fate as he sat tethered to a machine that drained blood from one arm and pumped it back into his body through the other arm.
After four hours, blood stem cells processed by the machine would be flown thousands of miles to a young child he has never met. A child whose name he does not know.
A child battling blood cancer.
This story unfolded in a Denver hospital in September. But it began 14 years earlier with a split-second decision in Las Vegas when Cridland was 24.
Before the child was born.
Im not a religious person by any means, Cridland, now 38, said. But I do believe that theres a lot of fate that takes place in our actions on a day-to-day basis.
The year is 2006. George W. Bush is president.
And Cridland, a recent UNLV graduate with a bachelors degree in journalism and media studies, had just left his part-time job with Vegas PBS for a full-time job with the local chapter of the Leukemia and Lymphoma Society.
Through his new job, Cridland soon found himself at a donation drive, hosted by a charity called Be the Match, for a family desperately searching for a bone marrow donor.
For patients diagnosed with leukemia or lymphoma, a bone marrow or cord blood transplant may be their only hope for a cure.
Cridland was there to work the event, but he drew inspiration from those around him getting swabbed. Whats the harm, he thought.
That day, his DNA was packaged and shipped off to be entered in the National Bone Marrow Registry.
He wasnt a match. Life went on, and eventually Cridland forgot about the swab.
In the meantime, he moved on to a job with the Clark County School District, got married, adopted a dog, had two children, bought a house, got another dog.
Fourteen years came and went, and now it was 2020.
The phone call
The call came at the best time, during arguably one of the worst years in modern history. The 2020 pandemic was in full swing. Protests over racism and police brutality had taken hold of a divided nation.
Cridland, a spokesman for the school district, needed something good to focus on.
But when that something good came calling earlier this year, he almost didnt answer. A toll-free number lit up the screen. A telemarketer maybe, or a scam?
Cridland surprised himself and took the call.
I dont know if you remember this, Cridland recalled a woman on the other end explaining. But you gave a cheek swab at one of our events, and theres a possibility that this cheek swab is a match for a child in need of stem cells or marrow to help them fight blood cancer.
The woman, an employee of Be the Match, ended the call with a question: Would you be willing to donate?
She gave Cridland the weekend to think it over. But for Cridland and his wife, who have two young children, it was a no-brainer.
Not long after, a second cheek swab confirmed what the woman had told Cridland during their phone call.
He was a match for the patient. In this case, that meant at least eight specific genetic markers in Cridlands DNA, called human leukocyte antigens, matched the patients DNA.
Every one individual has their own unique genetic DNA code, said Erica Sevilla, a spokeswoman for Be the Match. What were looking to attach to that code is protein markers that tell your body what cells belong in the body and what cells do not. Essentially, youre looking to match immune systems between the donor and the patient.
From there, the patients doctor will decide the best course for treatment.
According to Be the Match, many believe that the only way to donate blood stem cells is through a surgical procedure, during which the donor receives anesthesia and a needle is used to extract liquid marrow from the pelvic bone. But 79 percent of donations are done through a nonsurgical procedure known as a peripheral blood stem cell donation.
The doctor in Cridlands donation case chose the nonsurgical route.
During the week leading up to the donation, Be the Match sent a nurse to Cridlands home in Henderson once a day for five consecutive days to administer injections of a medication that increased the number of blood-forming cells in Cridlands bloodstream.
Cridland and his wife were flown to Denver for the procedure.
At times throughout the donation process, which spanned about five months from the first phone call to the day of the procedure, Cridland would find himself moved to tears, overcome by his gratitude for the chance to help save a young child.
To me, the crazy thing about all this is that my actions from 14 years ago have had a dramatic effect on how somebody else is living in 2020, he said in an interview this month at his home. With all the negativity weve seen this year, this one family may look at 2020 as the best year of their lives because of this one specific moment in my life that took place 14 years ago.
Even now, three months removed from donation day, Cridland at random will break down in tears.
Sometimes he thinks about his blood pumping through the childs body. How a piece of him will always be with that child. How someone he has never met, and may never meet, could be such a close genetic match to him.
How were all more alike than we think.
Epilogue
I wish I could take this feeling, put it in a can and throw a lid on top, Cridland said of his experience donating stem cells.
If that were possible, Cridland said, he would pass it around like a party favor but he cant.
So instead, hes hoping his story will inspire others, especially people of color, to join the registry and give the gift of a cure to another patient in need.
Currently, there is a severe shortage of diverse donors in the national registry, which consists of 22 million donors. More than 13 percent of the American population is Black, for example, yet only about 4 percent of registered donors are Black.
And the disparity is costing lives.
Matching is based on genetic markers that can be traced back to your grandparents and your great-grandparents, said Sevilla, the spokeswoman for Be the Match. Theyre traced back to the very origins of your family, so thats why people who are of European descent have an easier time finding a match, whereas people who descended from slavery, for example, have a harder time.
To join the National Bone Marrow Registry and request a cheek swab kit, visit http://www.join.bethematch.org.
Meanwhile, as of mid-December, Cridland knew only that the patient had received his stem cells. He wasnt sure, even, if hed ever meet the child.
Both parties must consent to meeting, and different countries operate under varied cooling-off periods. For some countries, a patient and a donor must wait two years before they can meet or even speak.
As a donor, Cridland was told the patients age, specific diagnosis and city and country of residence. But he is not allowed to disclose that information to protect the patients privacy.
According to Be The Match, 50 percent of all marrow or stem cell donations are international.
We are either exporting cells or importing cells, said Sevilla, the charity spokeswoman.
Cridland gave his consent for the patients family to reach out to him in the future. For now, its a waiting game.
If the moment comes that they try to connect, Ill be there, he said.
Contact Rio Lacanlale at rlacanlale@reviewjournal.com or 702-383-0381. Follow @riolacanlale on Twitter.
Continued here:
He got his cheek swabbed at 24. Nothing happened for 14 years. - Las Vegas Review-Journal