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Category Archives: Stem Cell Therapy

Rheumatoid Arthritis Stem Cell Therapy Market By Type (Allogeneic Mesenchymal Stem Cells, Bone Marrow Transplant, Adipose Tissue Stem Cells) and By…

Posted: October 16, 2021 at 2:56 am

250 Pages Rheumatoid Arthritis Stem Cell Therapy Market Survey by Fact MR, A Leading Business and Competitive Intelligence Provider

Rheumatoid arthritis stem cell therapy has been demonstrated to induce profound healing activity, halt arthritic conditions, and in many cases, reverse and regenerate joint tissue. Today, bone marrow transplant, adipose or fat-derived stem cells, and allogeneic mesenchymal stem cells (human umbilical cord tissue) are used for rheumatoid arthritis stem cell therapy.

The Market Research Survey by Fact.MR, highlights the key reasons behind increasing demand and sales of Rheumatoid Arthritis Stem Cell Therapy.Rheumatoid Arthritis Stem Cell Therapy market driversand constraints, threats and opportunities, regional segmentation and opportunity assessment, end-use/application prospects review are addressed in the Rheumatoid Arthritis Stem Cell Therapy market survey report. The survey report provides a comprehensive analysis of Rheumatoid Arthritis Stem Cell Therapy market key trends and insights on Rheumatoid Arthritis Stem Cell Therapy market size and share.

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Rheumatoid Arthritis Stem Cell Therapy Market: Segmentation

Tentatively, the global rheumatoid arthritis stem cell therapy market can be segmented on the basis of treatment type, application, end user and geography.

Based on treatment type, the global rheumatoid arthritis stem cell therapy market can be segmented into:

Based on application, the global rheumatoid arthritis stem cell therapy market can be segmented into:

Based on distribution channel, the global rheumatoid arthritis stem cell therapy market can be segmented into:

Key questions answered in Rheumatoid Arthritis Stem Cell Therapy Market Survey Report:

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Rheumatoid Arthritis Stem Cell Therapy Market: Key Players

The global market for rheumatoid arthritis stem cell therapy is highly fragmented. Examples of some of the key players operating in the global rheumatoid arthritis stem cell therapy market include Mesoblast Ltd., Roslin Cells, Regeneus Ltd, ReNeuron Group plc, International Stem Cell Corporation, TiGenix and others.

The report is a compilation of first-hand information, qualitative and quantitative assessment by industry analysts, inputs from industry experts and industry participants across the value chain.

Essential Takeaways from the this Market Report

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Hemostasis Valves MarketAccording to the latest research by Fact.MR, the Hemostasis Valves Market is set to witness steady growth during 2021-2031. The increasing advancement in the hemostasis valves industry will offer lucrative opportunities and an increasing number of interventional procedures is propelling the market growth.

Cosmetic Dentistry MarketThe global cosmetic dentistry market is estimated to witness significant growth during the forecast period of 2021-2031. This growth is factored in due to the rising consumer awareness and well-defined grooming interest in the aesthetical value of oral care.

Creatinine Testing MarketCreatinine testing involves the measurement of the level of creatinine, which is a product of muscle creatine catabolism and is thus a reliable indicator of kidney function by an indication that a rise in the level of creatinine may indicate Acute Kidney Injury or Chronic Kidney Disease.

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Worldwide Cell Therapy Consumables Industry to 2031 – Featuring Bio-Techne, Irvine Scientific and Sartorius Among Others – PRNewswire

Posted: October 16, 2021 at 2:56 am

DUBLIN, Oct. 12, 2021 /PRNewswire/ -- The "Cell Therapy Consumables Market by Type of Consumable, Type of Cell Therapy, Scale of Operation, Type of End-User and Key Geographical Regions: Industry Trends and Global Forecasts, 2021 - 2031" report has been added to ResearchAndMarkets.com's offering.

This report features an extensive study on the consumable providers within the cell therapy industry. The study also includes an elaborate discussion on the future potential of this evolving market.

According to the US Food and Drug Administration (FDA), there has been an evident increase in the number of cell and gene therapy products being evaluated in early phases of development. This can further be validated by the observed upsurge in the number of investigational new drug (IND) applications. In fact, more than 800 IND applications have been filed for ongoing clinical studies, indicating remarkable scientific progress and therapeutic promise of these breakthrough drug candidates. However, manufacturing of cell therapies is a complex and capital-intensive process fraught with a wide range of challenges. Some of the key concerns of contemporary innovators include raw material supply constraints, current facility limitations, high cost of ancillary materials (buffers, growth factors and media) used in upstream processes, regulatory and compliance-related issues, and inconsistencies related to quality attributes of the final product. Further, the onset of recent COVID-19 pandemic has created additional challenges for therapy developers, in terms of procuring the required raw materials, by disrupting well-established supply chains.

Recent reports indicate that the global demand for human serum albumin (a key component of cell culture media for use in a multitude of therapeutic and emerging biotech areas) has increased at an annual rate of 10%-15%. On the contrary, the use of animal components is highly disregarded by the US FDA, European Medicines Agency (EMA), and other regulatory bodies on the grounds that they pose an undesirable risk of transmitting infectious agents, such as prions (mad cow disease) and virus (HIV), as well as enable high batch-to-batch variation. Consequently, serum-free and xeno-free media have proven to be a promising alternative to serum derived components. In order to produce quality cellular therapies, several drug developers prefer to rely on third-party service providers for the supply of raw materials, such as cell culture medium, cell isolation kits and cell separation reagents.

Presently, over 60 service providers are actively engaged in providing consumable/raw material products for the production of cell therapies. The current consolidated market landscape is primarily dominated by the presence of large players, capturing a substantial proportion of the market share. In the recent past, many of the aforementioned service providers have also forged strategic alliances and/or acquired other players, in order to further enhance their respective service offerings. Given that the demand for cell therapies is indubitably rising, the corresponding opportunity for cell therapy consumable service providers is expected to witness steady growth, over the next decade.

Amongst other elements, the report features:

Key Questions Answered

Key Topics Covered:

1. PREFACE

2. EXECUTIVE SUMMARY

3. INTRODUCTION

4. MARKET LANDSCAPE4.1. Chapter Overview4.2. Cell Therapy Kit Providers: List of Players4.3. Cell Therapy Media Providers: List of Players4.4. Cell Therapy Reagent Providers: List of Players4.5. Analysis by Type of Consumable, Type of Cell Therapy and Application Area (Grid Representation)

5. COMPANY COMPETITIVENESS ANALYSIS5.1. Chapter Overview5.2. Key Assumptions and Parameters5.3. Methodology5.4. Company Competitiveness: Kit Providers5.5. Company Competitiveness: Media Providers5.6. Company Competitiveness: Reagent Providers

6. BRAND POSITIONING OF KEY INDUSTRY PLAYERS6.1. Chapter Overview6.2. Scope and Methodology6.3. Bio-Techne6.4. Miltenyi Biotec6.5. Sartorius6.6. STEMCELL Technologies6.7. Thermo Fisher Scientific

7. COMPANY PROFILES7.1. Chapter Overview7.2. Miltenyi Biotec7.2.1. Company Overview7.2.2. Product Portfolio7.2.3. Recent Developments and Future Outlook7.3. STEMCELL Technologies7.3.1. Company Overview7.3.2. Product Portfolio7.3.3. Recent Developments and Future Outlook7.4. Bio-Techne7.4.1. Company Overview7.4.2. Product Portfolio7.4.3. Recent Developments and Future Outlook7.5. Irvine Scientific7.5.1. Company Overview7.5.2. Product Portfolio7.5.3. Recent Developments and Future Outlook7.6. Thermo Fisher Scientific7.6.1. Company Overview7.6.2. Product Portfolio7.6.3. Recent Developments and Future Outlook7.7. Sartorius7.7.1. Company Overview7.7.2. Product Portfolio7.7.3. Recent Developments and Future Outlook7.8. BD Biosciences7.8.1. Company Overview7.8.2. Product Portfolio7.8.3. Recent Developments and Future Outlook7.9. Lonza7.9.1. Company Overview7.9.2. Product Portfolio7.9.3. Recent Developments and Future Outlook7.10. CellGenix7.10.1. Company Overview7.10.2. Product Portfolio7.10.3. Recent Developments and Future Outlook7.11. Corning7.11.1. Company Overview7.11.2. Product Portfolio7.11.3. Recent Developments and Future Outlook

8. RECENT DEVELOPMENTS AND INITIATIVES8.1. Chapter Overview8.2. Partnership Models8.3. Cell Therapy Consumables: Recent Partnerships and Collaborations8.4. Cell Therapy Consumables: Recent Expansions

9. LIKELY PARTNER ANALYSIS FOR CELL THERAPY CONSUMABLE PROVIDERS 9.1. Chapter Overview9.2. Scoring Criteria and Key Assumptions9.3. Scope and Methodology9.4. Key Potential Strategic Partners for Cell Therapy Consumable Providers9.3.1. Likely Partner Opportunities for Dendritic Cell Therapy Consumable Providers9.3.2. Likely Partner Opportunities for NK Cell Therapy Consumable Providers9.3.3. Likely Partner Opportunities for Stem Cell Therapy Consumable Providers9.3.4. Likely Partner Opportunities for T-Cell Therapy Consumable Providers

10. DEMAND ANALYSIS10.1. Chapter Overview10.2. Scope and Methodology10.3. Global Demand for Cell Therapy Consumables10.4. Global Demand for Cell Therapy Consumables for Planar Processes10.5. Global Demand for Cell Therapy Consumables for Suspension Processes10.6. Analysis by Scale of Operation10.7. Analysis by Region

11. MARKET FORECAST AND OPPORTUNITY ANALYSIS11.1. Chapter Overview11.2. Forecast Methodology11.3. Global Outsourced Cell Therapy Consumables Market, 2021-203111.4. Outsourced Cell Therapy Consumables Market, 2021-2031: Distribution by Type of Consumable11.5. Outsourced Cell Therapy Consumables Market, 2021-2031: Distribution by Type of Cell Therapy11.6. Outsourced Cell Therapy Consumables Market, 2021-2031: Distribution by Scale of Operation11.7. Outsourced Cell Therapy Consumables Market, 2021-2031: Distribution by Type of End-User11.8. Outsourced Cell Therapy Consumables Market, 2021-2031: Distribution by Geography

12. UPCOMING TRENDS AND FUTURE GROWTH OPPORTUNITIES12.1. Chapter Overview12.2. Emerging Trends Related to Cell Culture Media12.3. Automation of Cell Therapy Manufacturing Processes12.4. Single Use Systems and Technologies in Cell Therapy Manufacturing

13. IMPACT OF COVID-19 ON CELL THERAPY CONSUMABLES MARKET13.1. Chapter Overview13.2. Impact of COVID-19 Pandemic on Cell Therapy Consumables Market13.3. Impact on Future Market Opportunities for Cell Therapy Consumable Providers13.4. Current Opinions and Key Initiatives of Key Players13.5. Recuperative Strategies for Developer Businesses13.5.1. Strategies for Implementation in the Short / Mid Term13.5.2. Strategies for Implementation in the Long Term

14. CONCLUDING REMARKS14.1. Chapter Overview

15. INTERVIEW TRANSCRIPTS15.1. Chapter Overview15.2. Anant Kamath, Chief Operating Officer, Cellular Engineering Technologies15.2.1. Cellular Engineering Technologies: Key Highlights15.2.2. Interview Transcript15.3. Vishal G. Warke, Director R&D, Cell Culture and Immunology, HiMedia Laboratories and Gauri W. Page, Assistant R&D Manager, Animal Cell Culture, Himedia Laboratories15.3.1. HiMedia Laboratories: Key Highlights15.3.2. Interview Transcript

16. APPENDIX I: TABULATED DATA

17. APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS

For more information about this report visit https://www.researchandmarkets.com/r/2t5jj1

Media Contact:

Research and Markets Laura Wood, Senior Manager [emailprotected]

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Worldwide Cell Therapy Consumables Industry to 2031 - Featuring Bio-Techne, Irvine Scientific and Sartorius Among Others - PRNewswire

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Caring Cross to Lend Insight to "Democratization of Access to Transformative Cell and Gene Therapies" Panel at Meeting on the Mesa 2021 -…

Posted: October 16, 2021 at 2:56 am

GAITHERSBURG, Md., Oct. 13, 2021 /PRNewswire/ --Caring Cross, a 501(c)(3) non-profit dedicated to accelerating the development of advanced medicines and enabling access to cures for all patients, everywhere, announced that its Co-founder and Executive Director Boro Dropuli, Ph.D., M.B.A., will be a featured participant in the "Democratization of Access to Transformative Cell and Gene Therapies" panel at the Meeting on the Mesa 2021 conference in Carlsbad, CA. The annual meeting brings together senior executives and top decision-makers in the industry to advance cutting-edge research into and address commercialization opportunities involving cell and gene therapy.

Details of the presentation are as follows:

Panel:

"Democratization of Access to Transformative Cell and Gene Therapies"

Event:

Meeting on the Mesa 2021

Date:

Wednesday, October 13, 2021

Time:

7:15-8:45 a.m. PT

Registration:

Registration

"The clinical successes of CAR-T cell and other gene-therapies has opened the possibility for developing curative therapies for many diseases," Dr. Dropuli said. "However, the current price of such therapies limits patient access, particularly in underserved and less-developed communities around the world. It is important that both non-profit and for-profit stakeholders work together to lower the cost of such therapies with business models that are impactful, sustainable and bring value to investors and stakeholders alike."

Caring Cross recently launched its first initiative focused on CAR-T cell therapy utilizing manufacturing and distribution models that enable affordability and accessibility of these therapies to diverse patient populations and treatment indications. The non-profit aims to provide opportunities for both non-profit and for-profit innovators to change the way advanced medicines, like CAR-T cell therapies, are developed and how they are provided to patients in need.

In support of this endeavor, Caring Cross has created a community of highly experienced scientists, entrepreneurs and community advocates that are currently working with more than 100 clinical sites around the world to enable affordable and sustainable place-of-care manufacturing of CAR-T cells, with outstanding clinical results observed thus far.

Among Caring Cross' affiliations is the Global Gene Therapy Initiative (GGTI), which was formed in 2020 to tackle the barriers to low-and middle-income countries (LMIC) inclusion in gene therapy development and includes diverse stakeholders from all sectors. GGTI has set a goal of introducing two gene therapy Phase I clinical trials in two LMIC, Uganda and India, by 2024.

GGTI recently published a paper in Gene Therapy entitled, "Working Group Report for the Global Gene Therapy Initiative (GGTI)," that points to the massive gap between the companies, clinics, and researchers developing advanced therapeutic approaches and their availability to the patients who need them. The paper details the geographic exclusion of LMIC in gene therapy development and patients' lack of access to gene therapies in these areas, particularly for HIV infection and hemoglobinopathies global health crises impacting tens of millions of people primarily located in LMIC.

Caring Cross was also recently awarded a grant from the Bill and Melinda Gates Foundation to support the GGTI program for training of personnel from the Joint Clinical Research Center (JCRC) in Uganda on the methods for manufacturing gene-modified cell products. The training will occur at the Fred Hutchinson Cancer Research Center in Seattle under the direction of Dr. Jennifer Adair.

"The Global Gene Therapy Initiative, or GGTI, is an alliance of scientists, engineers, clinical investigators and community advocates that aim to accelerate access to validated gene therapies in low- and middle-income countries, by grassroots community involvement, fostering education and training, infrastructure development and implementation of clinical trials," Dr. Adair said. "Our goal is to implement clinical trials in countries like Uganda and India by 2024."

Dr. Cissy Kityo, Executive Director of the JCRC, commented: "We are pleased to receive support from the Bill and Melinda Gates Foundation to train our personnel on how to manufacture gene-modified cell therapy products locally at our facilities and plan to implement clinical trials in the future targeting diseases such as HIV and Sickle Cell Disease."

About Caring CrossCaring Cross is a 501(c)(3) non-profit dedicated to accelerating the development of advanced medicines and ensuring access to cures for all patients, everywhere. To enable its mission, Caring Cross is mobilizing a growing community of healthcare professionals, scientists, engineers, community advocates, donors, investors and business leaders to support the development of technologies and candidate medicines and technologies. Currently, Caring Cross is advancing several initiatives that aim to improve the accessibility, affordability and applicability of CAR-T technology and stem cell gene therapy. These opportunities include developing and implementing affordable solutions for the manufacture of CAR-T cells, advancing a decentralized, place-of-care cell manufacturing model, and developing its first therapeutic candidate, an anti-HIV duoCAR-T cell therapy designed to suppress HIV replication and eliminate HIV-expressing cells in people with HIV. A stem cell gene therapy for Sickle Cell Disease and Beta-Thalassemia is also in development. For more information on Caring Cross visit https://caringcross.org/.

CONTACTTiberend Strategic Advisors, Inc.InvestorsLisa Sher970-987-2654 [emailprotected]

Media Ingrid Mezo646-604-5150 [emailprotected]

SOURCE Caring Cross

http://www.caringcross.org

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Caring Cross to Lend Insight to "Democratization of Access to Transformative Cell and Gene Therapies" Panel at Meeting on the Mesa 2021 -...

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Why Jasper Therapeutics Stock Is Soaring Today – Yahoo Finance

Posted: October 16, 2021 at 2:56 am

Jasper Therapeutics Inc (NASDAQ: JSPR) is surging higher Wednesday after Oppenheimer analyst Jay Olson initiated coverage on the stock with an Outperform rating and announced a price target of $21.

The Oppenheimer analyst cited the potential of Jasper Therapeutics' conditioning agents for hematopoietic stem cell transplantation.

Jasper Therapeutics went public via special purpose acquisition company Amplitude Healthcare Acquisition Corporation at the end of September.

Jasper Therapeutics is a clinical-stage biotechnology company dedicated to enabling cures through hematopoietic stem cell therapy. It's focused on the development and commercialization of safer and more effective conditioning agents and stem cell engineering to allow for expanded use of stem cell transplantation and ex vivo gene therapy.

JSPR Price Action: Jasper Therapeutics is making new 52-week highs during Wednesday's trading session.

The stock was up about 111% at $15.27 per share at time of publication.

Latest Ratings for JSPR

Oct 2021

Oppenheimer

Initiates Coverage On

Outperform

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Why Jasper Therapeutics Stock Is Falling Today – Benzinga

Posted: October 16, 2021 at 2:56 am

Jasper Therapeutics Inc (NASDAQ: JSPR) is trading lower Thursday amidprofit taking after the stock rallied roughly 120% on Wednesday.

Jasper Therapeuticssurgedhigher Wednesday afterOppenheimer analyst Jay Olson initiatedcoverage on the stockwith anOutperform rating and announced aprice target of$21.

The Oppenheimer analyst cited the potential of Jasper Therapeutics' conditioning agents for hematopoietic stem cell transplantation.

Jasper Therapeutics went public via special purpose acquisition companyAmplitude Healthcare Acquisition Corporation at the end of September.

Jasper Therapeuticsis a clinical-stage biotechnology company dedicated to enabling cures through hematopoietic stem cell therapy. It'sfocused on the development and commercialization of safer and more effective conditioning agents and stem cell engineering to allow for expanded use of stem cell transplantation and ex vivo gene therapy.

JSPR Price Action:Jasper Therapeutics was down 16% at $12.42 at time of publication.

View More Analyst Ratings for JSPR View the Latest Analyst Ratings

2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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Why Jasper Therapeutics Stock Is Falling Today - Benzinga

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Safety of Stem Cell Therapy for Chronic Knee Pain Confirmed in New Study – SciTechDaily

Posted: August 5, 2021 at 2:00 am

A study released inSTEM CELLS Translational Medicinehas confirmed the safety of a novel type of cellular therapy for knee pain caused by osteoarthritis. Conducted by a multi-institutional team of researchers in Japan who had developed the new therapy, the study was designed to confirm that their treatment which involves transplanting the patients own mesenchymal stem cells (MSCs) into the affected knee did not cause tumors.

The results showed that five years after transplantation, osteoarthritis-related tears to the knee meniscus had healed and, just as importantly, none of the patients experienced any serious side effects from the treatment. The meniscus is a crescent-shaped cartilage in the knee joint that plays a role in shock absorption. Age-related damage to the meniscus often leads to the progression of osteoarthritis of the knee.

Chronic knee pain is a major issue for the aging, affecting approximately 25 percent of all adults, according to the Centers for Disease Control and Prevention (CDC). Osteoarthritis is the most common cause of this condition in people aged 50 and older. Along with pain, which can be debilitating, knee problems can significantly affect the persons mobility and quality of life.

Knee replacement surgery is the gold standard of treatment, with the majority of people experiencing a dramatic reduction in pain and, thus, improvement in their ability to live a normal life. However, though rare, such surgery does come with risks such as the possibility of infection.

Lead investigator Mitsuru Mizuno, DVM, Ph.D. and corresponding author Ichiro Sekiya, M.D., Ph.D. Credit: AlphaMed Press

Cellular therapies are showing great potential as a less invasive way to treat difficult-to-heal knee injuries. The team behind the current study, which included researchers from Tokyo Medical and Dental University, Kyoto University and Kazusa DNA Research Institute, recently developed a therapy involving the transplantation of MSCs derived from the knees soft tissue (the synovium) into the injured meniscus. MSCs are multipotent adult stem cells present in the umbilical cord, bone marrow, fat, dental and other body tissues. Their ability to secrete biologically active molecules that exert beneficial effects on injured tissues makes them a promising target in regenerative medicine.

But some stem cell treatments have been known to cause tumors, which is why the team wanted to ensure that their therapy was free of any negative side effects. In particular, they wanted to investigate the safety of any MSCs that might show a type of chromosomal disorder called trisomy 7.

Trisomy 7 occurs frequently in patients with severe knee disease such as osteoarthritis. The detection of trisomy 7 in epithelial cells has been associated with tumor formation. However, the safety of these cells after transplantation has not been investigated. Thats what we wanted to learn from this study, said corresponding author Ichiro Sekiya, M.D., Ph. D., director and professor of the Center for Stem Cell and Regenerative Medicine (CSCRM) at Tokyo Medical and Dental University.

Mitsuru Mizuno, DVM, Ph.D., assistant professor with CSCRM, served as the studys lead investigator. He reported on the results. We recruited 10 patients for the study and transplanted their own stem cells into the affected knee joints, then followed up with MRIs over the next five years. The images revealed that tears in the patients knee meniscus were obscured three years after transplantation. We also identified trisomy 7 in three of the patients, yet no serious adverse events including tumor formation were observed in any of them.

Dr. Sekiya added, Keep in mind that these were autologous MSCs used in our study, which means that the transplanted MSCs came from the patients themselves. Any problems that might arise in the case of allogeneic cells, which are donated by someone other than the patient, still need to be determined.

Nevertheless, we believe that these data suggest that MSCs with trisomy 7 are safe for transplantation into human knees and show much promise in treating osteoarthritis.

This study highlights the ability of a patients own stem cells to potentially heal torn cartilage in the knee, said Anthony Atala, M.D., Editor-in-Chief ofSTEM CELLS Translational Medicineand director of the Wake Forest Institute for Regenerative Medicine. These outcomes suggest a potential approach that could change the overall physical health of patients who suffer from osteoarthritis and experience debilitating joint pain. We look forward to the continuation of this research to further document clinical efficacy.

Reference: Transplantation of human autologous synovial mesenchymal stem cells with trisomy 7 into the knee joint and 5 years of follow-up by Mitsuru Mizuno, Kentaro Endo, Hisako Katano, Naoki Amano, Masaki Nomura, Yoshinori Hasegawa, Nobutake Ozeki, Hideyuki Koga, Naoko Takasu, Osamu Ohara, Tomohiro Morio and Ichiro Sekiya, 3 August 2021, STEM CELLS Translational Medicine.DOI: 10.1002/sctm.20-0491

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Asia-Pacific Cell Therapy Market 2021-2028 – Opportunities in the Approval of Kymriah and Yescarta – PRNewswire

Posted: August 5, 2021 at 2:00 am

DUBLIN, Aug. 4, 2021 /PRNewswire/ -- The "Asia Pacific Cell Therapy Market Size, Share & Trends Analysis Report by Use-type (Clinical-use, Research-use), by Therapy Type (Autologous, Allogeneic) and Segment Forecasts, 2021-2028" report has been added to ResearchAndMarkets.com's offering.

The Asia Pacific cell therapy market size is expected to reach USD 2.9 billion by 2028. The market is expected to expand at a CAGR of 14.9% from 2021 to 2028.

Rapid advancements in regenerative medicine are anticipated to provide effective solutions for chronic conditions. A substantial number of companies in the growing markets, such as India and South Korea, are striving to capitalize on the untapped opportunities in the market, thereby driving the market.

The growth is greatly benefitted by the fund and regulatory support from government bodies and regulatory agencies. For instance, in August 2020, the government of South Korea passed an Act on the Safety and Support of Advanced Regenerative Medical Treatment and Medicine to establish a regulatory system for patient safety during quality control and clinical trials and to strengthen the regulatory support for regenerative medicine development.

The implementation of the act is expected to enhance clinical studies and approvals of regenerative medicine in South Korea. Furthermore, CAR-T and TCR T-cell therapies have already revolutionized hematologic cancer treatment. With the onset of the COVID-19 pandemic, scientists are deciphering its potential against the novel coronavirus. The concept of using T cells against chronic viral infections, such as HIV and hepatitis B, has already been proposed.

Based on the previous research insights, Singapore-based Duke-NUS medical school's emerging infectious diseases research program demonstrated the utility of these immunotherapies in treating patients with COVID-19 infection.

Thus, an increase in research for use of cell therapies for COVID-19 treatment is expected to drive the market in Asian countries. In April 2021, a team of researchers from Japan used induced pluripotent stem cells (iPS) to find drugs that can effectively inhibit the coronavirus and other RNA viruses.

Key Topics Covered:

Chapter 1 Methodology and Scope

Chapter 2 Executive Summary2.1 Market Snapshot

Chapter 3 Cell Therapy Market Variables, Trends, and Scope3.1 Market Trends and Outlook3.2 Market Segmentation and Scope3.3 Market Dynamics3.3.1 Market driver analysis3.3.1.1 Rise in number of clinical studies for cellular therapies in Asia Pacific3.3.1.2 Expanding regenerative medicine landscape in Asian countries3.3.1.3 Introduction of novel platforms and technologies3.3.2 Market restraint analysis3.3.2.1 Ethical concerns3.3.2.2 Clinical issues pertaining to development & implementation of cell therapy3.3.2.2.1 Manufacturing issues3.3.2.2.2 Genetic instability3.3.2.2.3 Condition of stem cell culture3.3.2.2.4 Stem cell distribution after transplant3.3.2.2.5 Immunological rejection3.3.2.2.6 Challenges associated with allogeneic mode of transplantation3.3.3 Market opportunity analysis3.3.3.1 Approval of Kymriah and Yescarta across various Asian countries3.3.3.2 Developments in CAR T-cell therapy for solid tumors3.3.4 Market challenge analysis3.3.4.1 Operational challenges associated with cell therapy development & usage3.3.4.1.1 Volume of clinical trials for cell and gene therapy vs accessible qualified centers3.3.4.1.2 Complex patient referral pathway3.3.4.1.3 Patient treatment, selection, and evaluation3.3.4.1.4 Availability of staff vs volume of cell therapy treatments3.4 Penetration and Growth Prospect Mapping for Therapy Type, 20203.5 Business Environment Analysis3.5.1 SWOT Analysis; By factor (Political & Legal, Economic and Technological)3.5.2 Porter's Five Forces Analysis3.6 Regulatory Framework3.6.1 China3.6.1.1 Regulatory challenges & risk of selling unapproved cell therapies3.6.2 Japan

Chapter 4 Cell Therapy Market: COVID-19 Impact analysis4.1 Challenge's analysis4.1.1 Manufacturing & supply challenges4.1.2 Troubleshooting the manufacturing & supply challenges associated to COVID-194.2 Opportunities analysis4.2.1 Need for development of new therapies against SARS-CoV-24.2.1.1 Role of T-cell based therapeutics in COVID-19 management4.2.1.2 Role of mesenchymal cell-based therapeutics in COVID-19 management4.2.2 Rise in demand for supply chain management solutions4.3 Challenges in manufacturing cell therapies against COVID-194.4 Clinical Trial Analysis4.5 Key Market Initiatives

Chapter 5 Asia Pacific Cell Therapy CDMOs/CMOs Landscape5.1 Role of Cell Therapy CDMOs5.2 Key Trends Impacting Asia Cell Therapy CDMO Market5.2.1 Regulatory reforms5.2.2 Expansion strategies5.2.3 Rising investments5.3 Manufacturing Volume Analysis5.3.1 Wuxi Biologics5.3.2 Samsung Biologics5.3.3 GenScript5.3.4 Boehringer Ingelheim5.3.5 Seneca Biopharma, Inc.5.3.6 Wuxi AppTech5.4 Competitive Milieu5.4.1 Regional network map for major players

Chapter 6 Asia Pacific Cell Therapy Market: Use Type Business Analysis6.1 Market (Stem & non-stem cells): Use type movement analysis6.2 Clinical Use6.2.1 Market (stem & non-stem cells) for clinical use, 2017 - 2028 (USD Million)6.2.2 Market (stem & non-stem cells) for clinical use, by therapeutic area6.2.2.1 Malignancies6.2.2.1.1 Market (stem & non-stem cells) for malignancies, 2017 - 2028 (USD Million)6.2.2.2 Musculoskeletal disorders6.2.2.3 Autoimmune disorders6.2.2.4 Dermatology6.2.3 Market (stem & non-stem cells) for clinical use, by cell type6.2.3.1 Stem cell therapies6.2.3.1.1 Market, 2017 - 2028 (USD Million)6.2.3.1.2 BM, blood, & umbilical cord-derived stem cells/mesenchymal stem cells6.2.3.1.3 Adipose-derived stem cell therapies6.2.3.1.4 Other stem cell therapies6.2.3.2 Non-stem cell therapies6.3 Research Use

Chapter 7 Asia Pacific Cell Therapy Market: Therapy Type Business Analysis7.1 Market (Stem & Non-stem Cells): Therapy type movement analysis7.2 Allogeneic Therapies7.3 Autologous Therapies

Chapter 8 Asia Pacific Cell Therapy Market: Country Business Analysis8.1 Market (Stem & Non-stem Cells) Share by Country, 2020 & 2028

Chapter 9 Asia Pacific Cell Therapy Market: Competitive Landscape

For more information about this report visit https://www.researchandmarkets.com/r/3hdt1c

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Asia-Pacific Cell Therapy Market 2021-2028 - Opportunities in the Approval of Kymriah and Yescarta - PRNewswire

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Myelodysplastic Syndrome Treatment Options – Healthline

Posted: August 5, 2021 at 2:00 am

Myelodysplastic syndrome (MDS) refers to a group of bone marrow disorders that interfere with the healthy production of blood cells. Its a type of blood cancer.

Treatments for MDS can range from long-term medication to stem cell transplants. Your options depend on the type of MDS you have and how serious it is. You might also consider your age and overall health when choosing a treatment plan.

Various treatments can slow disease progression, relieve symptoms, and prevent complications. You can also try certain lifestyle changes and natural remedies that may help relieve your symptoms and improve your quality of life.

Your bone marrow produces immature blood cells, also called stem cells. These then develop into one of three types of mature blood cells:

If you have MDS, not all of these stem cells mature. As a result, immature cells can remain in the bone marrow or die. You will have lower levels of mature blood cells in your bloodstream.

A reduced mature blood cell count is a condition known as cytopenia, and its a main characteristic of MDS. A blood test known as a complete blood count (CBC) is one of the first diagnostic tests your doctor will order if they suspect you have MDS.

Removing bone marrow samples through aspiration and biopsy can also help your doctor better understand the nature of your blood marrow disorder. Once your doctor has diagnosed and treated your MDS, these tests can also show how well your bone marrow is responding to treatment.

You will often have a healthcare team if you have this type of disorder, which may include:

The team will develop a treatment plan thats partially based on the type of MDS you have. The World Health Organization (WHO) identifies six main types of MDS.

Your treatment plan may also be based on the prognostic score (outlook for survival) of the disease. MDS is different from most forms of cancer, which are grouped in stages and grades, because its scored on several factors, including:

Before you start MDS treatment, you might also consider your:

Next, well discuss each of the main treatment options for this group of diseases.

Supportive therapy is meant to treat MDS symptoms and prevent complications, rather than treat the underlying disorder itself. Supportive therapy is often used alongside other treatments.

Examples of supportive therapy include:

Lenalidomide is a type of medication called an immunomodulatory agent. Your doctor may suggest this oral medication if you have MDS and a certain genetic change known as an isolated del(5q) chromosome abnormality.

Lenalidomide helps boost red blood cell production in your bone marrow. Its designed to reduce your dependence on blood transfusions.

Experts in a 2017 research review called it an excellent option for MDS patients with low or intermediate disease risk. Potential side effects include:

Antithymocyte globulin is in a large group of drugs known as immunosuppressants that weaken the bodys immune response. Organ transplant recipients usually take them to help prevent rejection of the new organ. You may take antithymocyte globulin to keep your immune system from attacking stem cells in your bone marrow.

Immunosuppressant therapy may be appropriate for you if you have lower-risk MDS and havent had effective results with ESAs and transfusions. You might also try it if you have one or more autoimmune diseases.

One 2018 study found that antithymocyte globulin was effective in about 50 percent of the MDS cases studied.

Certain chemotherapy drugs, known as hypomethylating agents, activate specific genes in your stem cells to help them mature. Two examples of these agents are azacitidine and decitabine. These drugs are used when your doctor determines there is a serious risk for leukemia, which is a serious potential complication of MDS.

Chemotherapy can help improve blood cell counts, sometimes to the point where you no longer need transfusions, and reduce your risk of leukemia. Potential side effects include:

Other chemotherapy drugs may be given with the goal of killing atypical stem cells and allowing more of your healthy cells to mature.

While high-dose chemotherapy drugs can be very effective at sending MDS into remission, the side effects can be severe. You could experience a serious drop in white blood cells, and later, a greater risk of infections developing and progressing quickly.

A stem cell transplant involves removing some of your bone marrow, usually from the pelvic bone, and replacing it with bone marrow that produces healthy blood cells.

The procedure is usually reserved for more serious cases of MDS. Stem cell transplant is the closest treatment option to a cure, but its an invasive and challenging therapy. Because of this, stem cell transplant is limited to people who are considered healthy enough for both the procedure and the recovery process.

Doctors often use chemotherapy drugs with stem cell transplant to treat MDS. Together, they help support the growth of healthy blood cells to replace unhealthy or atypical cells.

While transplants are often very effective at achieving disease remission, particularly in certain patients, the Aplastic Anemia and MDS International Foundation says that a majority of MDS patients will see their condition return over time.

In addition to traditional medications and procedures to treat MDS, complementary or alternative medicine (CAM) may also help provide you with symptom relief. While these therapies may not affect blood cell production, they may help you cope with symptoms such as anxiety and stress that can come with a chronic disease such as MDS.

Consider some of these treatments and remedies after first discussing them with a healthcare professional:

MDS can affect anyone at any age but generally affects adults ages 70 and older. According to the American Cancer Society (ACS), about 10,000 people are diagnosed with MDS in the United States per year.

Disease outcomes vary considerably. Its difficult to predict someones outcome because people respond differently to treatment.

ACS survival statistics range from a median survival of 8.8 years for people with a very low risk score to less than 1 year for MDS patients with a very high risk score.

These survival rates are based on data that includes years before treatments like chemotherapy were available. Its important to remember that researchers are continuing to develop new treatments that may improve disease outcomes.

You may have no symptoms early on or if you have mild MDS. However, for most people with the disease, anemia (low red blood cell counts) and symptoms such as chronic fatigue and shortness of breath are common.

If you have low white blood cell counts, the risk of serious infection may always be present. Low platelet counts can lead to easy bruising and bleeding complications.

MDS is a type of blood cancer in which your bone marrow doesnt produce high enough levels of mature red blood cells, white blood cells, or platelets.

A variety of treatments are available to manage MDS, including blood transfusions, immunosuppressant drugs, chemotherapy, and stem cell transplants. Each treatment comes with its own risks, but your doctor or cancer treatment team will help guide you toward an approach that may work best for you.

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Fate Therapeutics Announces Treatment of First Patient in Landmark Phase 1 Clinical Trial of FT819, the First-ever iPSC-derived CAR T-Cell Therapy |…

Posted: August 5, 2021 at 2:00 am

DetailsCategory: DNA RNA and CellsPublished on Tuesday, 03 August 2021 10:03Hits: 758

Off-the-Shelf CAR T-cell Product Candidate Derived from Clonal Master iPSC Line with Novel CD19-specific 1XX CAR Integrated into TRAC Locus

Phase 1 Clinical Study will Evaluate Three Dosing Regimens of FT819 for Patients with Advanced B-cell Leukemias and Lymphomas

SAN DIEGO, CA, USA I August 02, 2021 I Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, announced today that the first patient has been treated with FT819, an off-the-shelf chimeric antigen receptor (CAR) T-cell therapy targeting CD19+ malignancies. FT819 is the first-ever CAR T-cell therapy derived from a clonal master induced pluripotent stem cell (iPSC) line, a renewable cell source that enables mass production of high quality, allogeneic CAR T cells with greater product consistency, off-the-shelf availability, and broader patient accessibility. FT819 is engineered with several first-of-kind features designed to improve the safety and efficacy of CAR T-cell therapy.

Remarkable clinical outcomes have been achieved through treatment with patient-derived CAR T-cell therapy, however, next-generation approaches are necessary to reach more patients who are in need of these highly-effective therapies, said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. Treatment of the first-ever patient with FT819 ushers in a new era for off-the-shelf CAR T-cell therapy, with the potential to overcome the real-world limitations of existing patient- and donor-derived therapeutic approaches and unlock the full potential of CAR T-cell therapy. We would like to thank our collaborators at Memorial Sloan Kettering Cancer Center, whose partnership over the past five years has profoundly contributed to this landmark achievement.

FT819 was designed to specifically address several limitations associated with the current generation of patient- and donor-derived CAR T-cell therapies. Under a collaboration with Memorial Sloan Kettering Cancer Center (MSK) led by Michel Sadelain, M.D., Ph.D., Director, Center for Cell Engineering and Head, Gene Expression and Gene Transfer Laboratory, the Company incorporated several first-of-kind features into FT819 including:

The multi-center Phase 1 clinical trial of FT819 is designed to determine the recommended Phase 2 dose and schedule of FT819 and assess its safety and clinical activity in adult patients with relapsed/refractory acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), and B-cell lymphomas (BCL). Three treatment regimens will be independently evaluated for each type of malignancy in dose escalation: Regimen A as a single dose of FT819; Regimen B as a single dose of FT819 with IL-2 cytokine support; and Regimen C as three fractionated doses of FT819. For each indication and regimen, dose-expansion cohorts may be enrolled to further evaluate the clinical activity of FT819. The first patient with relapsed / refractory ALL was enrolled in Regimen A and received a dose of 90 million cells.

At the 24th American Society of Gene & Cell Therapy Annual Meeting held in May 2021, the Company presented preclinical data demonstrating that FT819 exhibits uniform 1XX CAR expression with complete elimination of endogenous TCR expression. The product candidate was shown to contain a stem- and central-memory T-cell phenotype, and had high-level expression of the activation marker CD25 and the trafficking marker CXCR4 and very low-level expression of the checkpoint proteins PD1, TIM3, CTLA4 and LAG3. Additionally, data from functional assessments showed that FT819 had potent antigen-specific cytolytic activity in vitro against CD19-expressing leukemia and lymphoma cell lines comparable to that of healthy donor-derived CAR T cells, and persisted and maintained tumor clearance in the bone marrow in an in vivo disseminated xenograft model of lymphoblastic leukemia.

Pursuant to a license agreement with MSK, Fate Therapeutics has an exclusive license for all human therapeutic use to U.S. Patent No. 10,370,452, which covers compositions and uses of effector T cells expressing a CAR, where such T cells are derived from a pluripotent stem cell including an iPSC. In addition to the patent rights licensed from MSK, the Company owns an extensive intellectual property portfolio that broadly covers compositions and methods for the genome editing of iPSCs using CRISPR and other nucleases, including the use of CRISPR to insert a CAR in the TRAC locus for endogenous transcriptional control.

Fate Therapeutics haslicensedintellectual propertyfrom MSK on which Dr. Sadelain is aninventor.As a result of the licensing arrangement, MSK has financial interests related to Fate Therapeutics.

About Fate Therapeutics iPSC Product PlatformThe Companys proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that are designed to be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Companys first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Companys platform is uniquely designed to overcome numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics iPSC product platform is supported by an intellectual property portfolio of over 350 issued patents and 150 pending patent applications.

About FT819FT819 is an investigational, universal, off-the-shelf, T-cell receptor (TCR)-less CD19 chimeric antigen receptor (CAR) T-cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line, which is engineered with the following features designed to improve the safety and efficacy of CAR19 T-cell therapy: a novel 1XX CAR signaling domain, which has been shown to extend T-cell effector function without eliciting exhaustion; integration of the CAR19 transgene directly into the T-cell receptor alpha constant (TRAC) locus, which has been shown to promote uniform CAR19 expression and enhanced T-cell potency; and complete bi-allelic disruption of TCR expression for the prevention of graft-versus-host disease (GvHD). FT819 demonstrated antigen-specific cytolytic activity in vitro against CD19-expressing leukemia and lymphoma cell lines comparable to that of primary CAR T cells, and persisted and maintained tumor clearance in the bone marrow in an in vivo disseminated xenograft model of lymphoblastic leukemia (Valamehr et al. 2020). FT819 is being investigated in a multi-center Phase 1 clinical trial for the treatment of relapsed / refractory B-cell malignancies, including B-cell lymphoma, chronic lymphocytic leukemia, and acute lymphoblastic leukemia (NCT04629729).

About Fate Therapeutics, Inc.Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Companys immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit http://www.fatetherapeutics.com.

SOURCE: Fate Therapeutics

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Fate Therapeutics Announces Treatment of First Patient in Landmark Phase 1 Clinical Trial of FT819, the First-ever iPSC-derived CAR T-Cell Therapy |...

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Colin Jackson health: Im in constant pain Athlete to undergo stem cell therapy to help – Express

Posted: August 5, 2021 at 2:00 am

Colin Ray Jackson, CBE, 54, is a Welsh former sprinter and hurdling Olympic silver medal champion. Colins world record for his 60 metres hurdles stood for an incredible 27 years. As with most athletes of his calibre, Colin suffers with ongoing injuries from his sports days and will be undergoing a treatment to reduce the pain which Mike Tyson recently underwent too.

In recent years, stem cell therapy has been hailed as a miracle cure for many conditions, from wrinkles to spinal repair.

A stem cell is an immature, basic cell that has not yet developed to become, say, a skin cell or a muscle cell or a nerve cell.

There are different types of stem cells that the body can use for different purposes.

There is evidence that stem cell treatments work by triggering damaged tissues in the body to repair themselves, often referred to as regenerative therapy.

In animal studies, stem cell treatments have shown promise for various diseases, including heart disease, Parkinsons disease and muscular dystrophy.

A study undertaken by Dr Timothy McGuine found that 34 percent of athletes involved in the one-year study were more likely to report a history of knee and hip injuries.

Additionally, he found that specialised athletes, such as those competing in the Olympic games, were twice as likely to sustain a gradual onset or repetitive use injuries than athletes who did not specialise.

Dr McGuine also found that these athletes who find themselves competing year-round, stressing the same muscles and movements, and predisposed to the symptoms of burnout are at higher risk of long-term injuries.

Many doctors and athletes use stem cell therapy to treat sports injuries, such as Achilles tendinopathy or damaged knee ligaments, said Sports Health.

The site continued: While increasing in popularity, stem cell therapy is not considered standard practice by sports medicine doctors and not covered by most insurance companies.

The process of collecting stem cells is often called harvesting. Physicians usually harvest stem cells from the patients fat, blood, or bone marrow.

Many physicians who use stem cell therapy hypothesize that, when placed into a certain environment, stem cells can transform to meet a certain need.

Other sports stars who underwent stem cell therapy for long-term injuries included Cristiano Ronaldo, Rafael Nadal and most recently Mike Tyson.

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Colin Jackson health: Im in constant pain Athlete to undergo stem cell therapy to help - Express

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