New Cedars-Sinai Biomanufacturing Center to Spur Cell Therapies – Newswise

Newswise LOS ANGELES (Dec. 4, 2020) -- Cedars-Sinai has launched a center to manufacture the next generation of stem cell and gene therapies that will enable biomedical researchers, government medical programs, commercial entities and others to develop new biologic drugs and propel novel disease discoveries.

Biologic drugs are produced from living organisms or contain components of living organisms, such as cells, proteins or genes.

"TheCedars-Sinai Biomanufacturing Centerleverages our world-class stem-cell expertise, which already serves scores of clients, to provide a much-needed biomanufacturing facility in Southern California," saidClive Svendsen, PhD, executive director of the Cedars-Sinai Board of Governors Regenerative Medicine Institute. "It is revolutionary by virtue of elevating regenerative medicine and its therapeutic possibilities to an entirely new level-repairing the human body."

Among the facility's initial clients is the Department of Defense, which has asked Cedars-Sinai scientists to manufacture banks of stem cells from multiple healthy volunteers for later use in repairing vascular injuries sustained by military personnel in combat.

The core technology of the Cedars-Sinai Biomanufacturing Center involves production of specialized cells known as induced pluripotent stem cells, or iPSCs. Scientists make iPSCs by genetically converting adult blood cells into cells that can self-renew indefinitely and differentiate into nearly any type of tissue. Each resulting cell carries the exact DNA of the person who donated the blood sample.

"IPSCs are powerful tools for understanding human disease and developing therapies," saidDhruv Sareen, PhD, executive director of the Biomanufacturing Center and director of the induced pluripotent stem cell facility at the Regenerative Medicine Institute. "These cells enable us to truly practiceprecision medicineby developing drug treatments tailored to the individual patient or groups of patients with similar genetic profiles."

The Biomanufacturing Center is designed to address a critical bottleneck in bringing cell- and gene-based therapies to the clinic. It will help relieve a nationwide shortage of facilities that can scale up production of cells for drug products that consistently meet current good manufacturing practice (cGMP) standards for strength, quality, and purity. These standards, set by the U.S. Food and Drug Administration, must be met when producing pharmaceuticals for use in humans.

To comply with the federal standards, the new Cedars-Sinai center features nine "clean rooms" that maintain rigorously aseptic conditions for handling of all biomaterials. These rooms are supported by staging areas, gowning rooms, quality control laboratories and storage rooms with ample freezers and liquid nitrogen tanks.

Other sections of the Biomanufacturing Center are devoted to research and production of iPSC cells, technology and development, training and collaboration laboratories, offices, and facilities maintenance equipment. Overall, the center occupies more than 28,000 square feet.

"Our expansive facilities provide complete, end-to-end support of biomedical research and development of cell therapies that are 'living medicines,'" said Sareen, assistant professor of Biomedical Sciences. "We enable our clients to explore and create new types of cells, use them to make discoveries about diseases and transform the resulting biomaterials into cGMP-compliant therapies for testing in clinical trials."

The recent grand opening of the Biomanufacturing Center, hosted on a virtual platform by Cedars-Sinai leadership, was attended by representatives of local and federal governments, biotechnology companies, funding organizations and other stakeholders. It was followed by another Cedars-Sinai virtual event, a "Symposium on Translational Medicine and Biomanufacturing," that drew world-renowned keynote speakers from academia and industry and hundreds of attendees to explore the latest developments in these fields.

"Our new Biomanufacturing Center reaffirms Cedars-Sinai's commitment to deliver the finest clinical care for our patients-and patients everywhere-by expanding the frontiers of medical science," said Svendsen, professor of Biomedical Sciences and Medicine.

Read more on the Cedars-Sinai Blog:What Are Induced Pluripotent Stem Cells?

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New Cedars-Sinai Biomanufacturing Center to Spur Cell Therapies - Newswise

Magenta Therapeutics and bluebird bio Announce a Phase 2 Clinical Trial Collaboration to Evaluate Magenta’s MGTA-145 for Mobilizing and Collecting…

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Magenta Therapeutics (NASDAQ: MGTA) and bluebird bio, Inc. (NASDAQ: BLUE) today announced an exclusive clinical trial collaboration to evaluate the utility of MGTA-145, in combination with plerixafor, for mobilization and collection of stem cells in adults and adolescents with sickle cell disease (SCD). The data from this clinical trial could provide proof-of-concept for MGTA-145, in combination with plerixafor, as the preferred mobilization regimen for patients with SCD. bluebird bios experience with plerixafor as a mobilization agent in sickle cell disease aligns with Magentas combination therapy approach, utilizing MGTA-145 plus plerixafor with potential to achieve safe, rapid and reliable mobilization of sufficient quantities of high-quality stem cells to improve outcomes associated with stem cell transplantation. Under the collaboration, the stem cells will be fully characterized, and Magenta will undertake preclinical studies to evaluate the ability of these cells to be gene corrected and engrafted in mouse models. The companies will co-fund the clinical trial and Magenta will retain all rights to its product candidate.

We are excited to build upon our leading position in the field of ex-vivo gene therapy and the promising clinical data with LentiGlobin in SCD with a collaboration focused on achieving improved stem cell mobilization, said Dave Davidson, M.D., chief medical officer, bluebird bio. In this initial study, we hope to establish whether the combination of plerixafor with MGTA-145 can generate appropriate CD34+ stem cells with a single round of mobilization. If successful, we hope to evaluate this novel mobilization regimen with LentiGlobin to make another step forward in the treatment of patients with SCD.

Achieving reliable and rapid stem cell mobilization and a simplified collection process can ensure the entire patient experience is optimal with respect to therapeutic outcome. The incorporation of bluebird bios experience in this area of treatment will be immensely valuable in further developing MGTA-145 plus plerixafor to address the remaining unmet needs in gene therapy approaches for diseases like sickle cell disease, said John Davis Jr., M.D., M.P.H., M.S., Head of Research & Development and Chief Medical Officer, Magenta Therapeutics. We look forward to collaborating with bluebird bio to evaluate MGTA-145 as the preferred mobilization option for people with sickle cell disease.

SCD is a serious, progressive and debilitating genetic disease caused by a mutation in the -globin gene that leads to the production of abnormal sickle hemoglobin (HbS), causing red blood cells (RBCs) to become sickled and fragile, resulting in chronic hemolytic anemia, vasculopathy and painful vaso-occlusive events (VOEs). For adults and children living with SCD, this means unpredictable episodes of excruciating pain due to vaso-occlusion as well as other acute complicationssuch as acute chest syndrome (ACS), stroke, and infections, which can contribute to early mortality in these patients.

Currently available mobilization drugs, including granulocyte-colony stimulating factor (G-CSF), a commonly used mobilization agent administered over the course of five to seven days in other transplant settings, is not used in sickle cell disease because it can trigger vaso-occlusive crises and even death in adults and adolescents. Plerixafor is used to mobilize a patients stem cells for collection prior to transplant and while an available treatment option, multiple cycles of apheresis and collection may sometimes be required to generate sufficient stem cells for gene therapy. Magenta is developing MGTA-145, in combination with plerixafor, to be the preferred mobilization regimen for rapid and reliable mobilization and collection of hematopoietic stem cells (HSCs) to improve stem cell transplantation outcomes in multiple disease areas, including genetic diseases such as sickle cell disease, as well as blood cancers and autoimmune diseases.

About Magenta Therapeutics MGTA-145

MGTA-145, in combination with plerixafor, has demonstrated, in a recently completed Phase 1 study in healthy volunteers, it can rapidly and reliably mobilize high numbers of functional stem cells in a single day, without the need for G-CSF. MGTA-145 works in combination with plerixafor to harness a physiological mechanism of stem cell mobilization to rapidly and reliably mobilize HSCs for collection and transplant across multiple indications.

Additionally, as shown in preclinical studies, stem cells mobilized with MGTA-145 can be efficiently gene-modified and are able to engraft, potentially allowing for safer and more efficient mobilization for gene therapy approaches to treat sickle cell disease and other genetic diseases.

Magenta completed its Phase 1 trial of MGTA-145 in healthy volunteers, demonstrating MGTA-145 was well tolerated and enables same-day dosing, mobilization and simplified collection of sufficient stem cells for transplant, meeting all primary and secondary endpoints.

About bluebird bio, Inc.

bluebird bio is pioneering gene therapy with purpose. From our Cambridge, Mass., headquarters, were developing gene and cell therapies for severe genetic diseases and cancer, with the goal that people facing potentially fatal conditions with limited treatment options can live their lives fully. Beyond our labs, were working to positively disrupt the healthcare system to create access, transparency and education so that gene therapy can become available to all those who can benefit.

bluebird bio is a human company powered by human stories. Were putting our care and expertise to work across a spectrum of disorders: cerebral adrenoleukodystrophy, sickle cell disease, -thalassemia and multiple myeloma, using gene and cell therapy technologies including gene addition, and (megaTAL-enabled) gene editing.

bluebird bio has additional nests in Seattle, Wash.; Durham, N.C.; and Zug, Switzerland. For more information, visit bluebirdbio.com.

Follow bluebird bio on social media: @bluebirdbio, LinkedIn, Instagram and YouTube.

LentiGlobin and bluebird bio are trademarks of bluebird bio, Inc.

About Magenta Therapeutics

Magenta Therapeutics is a clinical-stage biotechnology company developing medicines to bring the curative power of immune system reset through stem cell transplant to more patients with autoimmune diseases, genetic diseases and blood cancers. Magenta is combining leadership in stem cell biology and biotherapeutics development with clinical and regulatory expertise, a unique business model and broad networks in the stem cell transplant world to revolutionize immune reset for more patients.

Magenta is based in Cambridge, Mass. For more information, please visit http://www.magentatx.com.

Follow Magenta on Twitter: @magentatx.

Forward-Looking Statement

This press release may contain forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as may, will, could, should, expects, intends, plans, anticipates, believes, estimates, predicts, projects, seeks, endeavour, potential, continue or the negative of such words or other similar expressions can be used to identify forward-looking statements. The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation risks set forth under the caption Risk Factors in Magentas Annual Report on Form 10-K filed on March 3, 2020, and in bluebird bios Annual Report on Form 10-K filed on February 18, 2020, as updated by each companys most recent Quarterly Report on Form 10-Q and its other filings with the Securities and Exchange Commission. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although Magenta and bluebird bio believe that the expectations reflected in the forward-looking statements are reasonable, neither Magenta nor bluebird bio can guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, except as required by law, neither Magenta or bluebird bio, nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. Neither Magenta nor bluebird undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

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Magenta Therapeutics and bluebird bio Announce a Phase 2 Clinical Trial Collaboration to Evaluate Magenta's MGTA-145 for Mobilizing and Collecting...

Global Single-cell Analysis Market Research Report 2020-2026 Featuring Major Players and Companies to Watch in the Future – PRNewswire

DUBLIN, Dec. 1, 2020 /PRNewswire/ -- The "Single-cell Analysis Market by Product, Cell Type, Technique, End User, and by Geography - Forecast to 2026" report has been added to ResearchAndMarkets.com's offering.

Single-cell Analysis Market is predicted to grow at a CAGR of ~17.1%. The market is predicted to reach $2005 million in 2026 from $763.4 million in 2020.

The information collected from this analysis is significant for cancer research for the discovery of tumor cells and genetic diagnosis. The factors such as advanced technology in products of single-cell analysis, increasing preference for customized medicine and rapidly increasing various chronic diseases such as cancer, which fuel the demand for the single-cell analysis market. However, the expensive products in the single-cell analysis are restraining market growth.

Single-cell analysis is the examination & study of proteins, study of small molecules, and other cells at the single-cell level. This analysis allows the study of variations of cell-to-cell in the group of cells. The objective of the single-cell analysis is to gain insight into the mechanisms of cellular functionality, which requires an understanding of each of the cellular components, including protein content, DNA, and RNA, as well as the cellular metabolites.

In the product based segmentation consumables segment is expected to have the largest share in the market. The reasons for the demand for consumables products are regularly purchasing the consumables compared to the instruments and the significant usage of consumables in the research and genetic exploration and segregation of RNA and DNA.

Based on cell type segmentation, the human cell segment is having the largest share in the market. The human cell is greatly used in the research laboratories due to the rising incidence of infectious diseases in the elderly population and the high investments in stem cell research.

On the bases of technique, the next-generation sequencing segment is expected to have the largest share in the market due to the increasing chronic diseases and next-generation sequencing allowing researchers to perform various applications.

Further, based on end-user segmentation, the academic and research laboratories segment is expected to have the largest share in the market. The increasing number of colleges and universities of medical and high investments in life science research are the factors accelerating the demand for single-cell analysis.

Moreover, based on the geography Asia Pacific region is playing a vital role in the market share compared to other regions due to rising number of patients in countries such as China and India, growing investments in the research and development in this field and outsourcing of drug discovery services to the Asia Pacific region. In addition, North America is the second-largest contributor to the market due to the high expenditure in the research and development and increased scope for stem cell research in this region.

The single-cell analysis market is expanding globally due to the increasingly advanced technology in the single-cell analysis products. The major factors accelerating the single-cell analysis market include rapidly increasing chronic diseases and cancer cases all over the world, increasing biotechnology & biopharmaceutical industries, and life science research. Although, due to high competition, the persistence of new entrants and small players is difficult in the market, and this is a challenge for market growth. The emerging markets in Asia are the future opportunities for the market.

The key market competitors in the market are Becton, Dickinson and Company, Danaher Corporatio, Merck Millipore, Qiagen N.V., Thermo Fisher Scientific, Inc, General Electric Company, BARCO, Promega Corporation, Shanghai Goodview Electronics, Fluidigm Corporation, Agilent Technologies, Inc, Nanostring Technologies, Inc., Tecan Group Ltd, Sartorius AG, LUMINEX CORPORATION, Takara Bio Inc., Takara Bio Inc., Fluxion Biosciences and Menarini Silicon Biosystems.

Moreover, the single-cell analysis has the largest scope in cancer research for the detection of the various tumor cells, preimplantation, and genetic diagnosis as the drastic increase in the cancer cases globally. The government is also supporting financially for cell-based research.

Key Topics Covered:

1. Executive Summary

2. Industry Outlook

3. Market Snapshot

3.1. Market Definition

3.2. Market Outlook

3.3. PEST Analysis

3.4. Porter Five Forces

3.5. Related Markets

4. Market characteristics

4.1. Market Evolution

4.2. Market Trends and Impact

4.3. Advantages/Disadvantages of Market

4.4. Regulatory Impact

4.5. Market Offerings

4.6. Market Segmentation

4.7. Market Dynamics

4.8. DRO - Impact Analysis

5. Technique: Market Size & Analysis

5.1. Overview

5.2. Consumables

5.2.1. Beads

5.2.2. Microplates

5.2.3. Reagents

5.2.4. Assay Kits

5.2.5. Other Consumables

5.3. Instruments

5.3.1. Flow Cytometers

5.3.2. NGS Systems

5.3.3. PCR Instruments

5.3.4. Spectrophotometers

5.3.5. Microscopes

5.3.6. Cell Counters

5.3.7. HCS Systems

5.3.8. Microarrays

5.3.9. Other Instruments

6. Cell Type: Market Size & Analysis

6.1. Overview

6.2. Human Cells

6.3. Animal Cells

6.4. Microbial Cells

7. Technique: Market Size & Analysis

7.1. Overview

7.2. Flow Cytometry

7.3. Next-generation Sequencing

7.4. Polymerase Chain Reaction

7.5. Microscopy

7.6. Mass Spectrometry

7.7. Other Techniques

8. End User: Market Size & Analysis

8.1. Overview

8.2. Academic & Research Laboratories

8.3. Biotechnology & Pharmaceutical Companies

8.4. Hospitals & Diagnostic Laboratories

8.5. Cell Banks & IVF Centers

9. Geography: Market Size & Analysis

9.1. Overview

9.2. North America

9.3. Europe

9.4. Asia Pacific

9.5. Rest of the World

10. Competitive Landscape

10.1. Competitor Comparison Analysis

10.2. Market Developments

10.3. Mergers and Acquisitions, Legal, Awards, Partnerships

10.4. Product Launches and execution

11. Vendor Profiles

11.1. Becton, Dickinson and Company

11.2. Danaher Corporation

11.3. Merck Millipore.

11.4. Qiagen N.V.

11.5. Thermo Fisher Scientific, Inc

11.6. General Electric Company

11.7. BARCO

11.8. Promega Corporation

11.9. Shanghai Goodview Electronics

12. Companies to Watch

12.1. Fluidigm Corporation

12.2. Agilent Technologies, Inc

12.3. Nanostring Technologies, Inc.

12.4. Tecan Group Ltd

12.5. Sartorius AG

12.6. LUMINEX CORPORATION

12.7. Takara Bio Inc.

12.8. Fluxion Biosciences

12.9. Menarini Silicon Biosystems

Companies Mentioned

Becton

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Global Single-cell Analysis Market Research Report 2020-2026 Featuring Major Players and Companies to Watch in the Future - PRNewswire

Cell Therapy Technologies Market | Extensive Information on a Plethora of Aspects Related to the Growth of the Market – BioSpace

The cell therapy technologies market is expected to gain immense growth opportunities through the forecast period of 2019-2029 owing to the rising influence of cell therapies across the life sciences sector. The overwhelming need for novel and enhanced therapies for a variety of diseases and disorders may bring extensive growth prospects for the cell therapy technologies market during the forecast period.

The increased funding by the government may also prove to be a great growth prospect for the cell therapy technologies market. The precision medicine sector is evolving at a rapid rate across the globe. In this, a patient is given personalized treatment and is useful in making more accurate decisions. Thus, this factor may boost the growth of the cell therapy technologies market.

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Cellular therapy is the transplantation of human cells to replace cells or tissues. This therapy can be used for treating various diseases and disorders. The evolution of cell therapy technologies is bringing immense advancements across the sector. This therapy is used mainly for nervous system disorders and cancer. The growing cases of these diseases may further invite promising growth.

On the basis of product, the cell therapy technologies market can be segmented into consumables, cell processing equipment, single-use equipment, other equipment, and systems and software. Based on cell type, the cell therapy technologies market can be classified into stem cells, T-cells, and other cells. Cell therapy technology is utilized expansively in biopharmaceutical and biotechnology companies and CROs, and research institutes and cell banks.

The enhancements in cell therapy technology research through immense investments from various sectors may invite prominent growth prospects for the cell therapy technologies market.

This report has extensive information on a plethora of aspects related to the growth of the cell therapy technologies market. The L.E.A.P mechanism applied by the researchers enables a 360-degree view of the cell therapy technologies market. The CXOs derive the perfect information that allows them to chalk out their business strategy accordingly. This report also has scrutinized information about the novel coronavirus outbreak and its effect on the cell therapy technologies market.

Cell Therapy Technologies Market: Competitive Insights

The cell therapy technologies market is highly fragmented. Numerous players are involved in intense competition for gaining a prominent position among the end-users. The players are also involved in expansion activities through mergers and acquisitions. Some well-entrenched players in the cell therapy technologies market are Danaher Corporation, CellGenix GmbH, IxCells Biotechnology, Wilson Wolf Corporation, SIRION Biotech GmbH, Dickinson and Company, and FUJIFILM Irvine Scientific.

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Cell Therapy Technologies Market: COVID-19 Impact

The COVID-19 impact may offer bright opportunities for the cell therapy technologies market to gain growth. The rising transmission of COVID-19 has led to rapid research and development activities in terms of an effective drug or vaccine. Cell-based research and technologies play an important role in the discovery of vaccines. Hence, this aspect may bring expansive growth prospects for the cell therapy technologies market.

Cell Therapy Technologies Market: Regional Prospects

The cell therapy technologies market in North America may gain a dominant position throughout the forecast period of 2019-2029. The maximizing research and development activities across the region for a good COVID-19 vaccine may bring profitable growth for the cell therapy technologies market. Robust healthcare expenditure, rising disposable income, and growing healthcare awareness may invite promising growth.

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About TMR Research

TMR Research is a premier provider of customized market research and consulting services to business entities keen on succeeding in todays supercharged economic climate. Armed with an experienced, 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.

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Cell Therapy Technologies Market | Extensive Information on a Plethora of Aspects Related to the Growth of the Market - BioSpace

Stem Cell Therapy Market Research Report Forecast to 2029 (Includes Business Impact of COVID-19) – Cheshire Media

Trusted Business Insights answers what are the scenarios for growth and recovery and whether there will be any lasting structural impact from the unfolding crisis for the Stem Cell Therapy market.

Trusted Business Insights presents an updated and Latest Study on Stem Cell Therapy Market 2020-2029. The report contains market predictions related to market size, revenue, production, CAGR, Consumption, gross margin, price, and other substantial factors. While emphasizing the key driving and restraining forces for this market, the report also offers a complete study of the future trends and developments of the market.The report further elaborates on the micro and macroeconomic aspects including the socio-political landscape that is anticipated to shape the demand of the Stem Cell Therapy market during the forecast period (2020-2029). It also examines the role of the leading market players involved in the industry including their corporate overview, financial summary, and SWOT analysis.

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Abstract, Snapshot, Market Analysis & Market Definition: Stem Cell Therapy Market Industry / Sector Trends

Stem Cell Therapy Market size was valued at USD 7.8 billion in 2018 and is expected to witness 10.2% CAGR from 2019 to 2025.

U.S. Stem Cell Therapy Market Size, By Type, 2018 & 2025 (USD Million)

Rising prevalence of chronic diseases will positively impact the stem cell therapy market growth. Cardiovascular diseases, neurological disorders and other chronic conditions have resulted in high mortality over past few years. Conventional therapeutic methods and treatments are currently replaced due to lack of efficiency and efficacy. Recently developed stem cell therapies are capable of replacing defective cells to treat diseases that has reduced morbidity drastically. Therefore, people have now started relying on stem cell therapy that has long term positive effects.

Advancements in stem cell therapy in developed regions such as North America and Europe have boosted the industry growth. Since past few years, there have been several researches carried out for stem cell therapy. Currently developed stem cell therapies have shown positive outcomes in treatment of leukemia. Similarly, due to advancements in regenerative medicine, several other chronic conditions such as muscular dystrophy and cardiovascular diseases also have been cured. Aforementioned factors have surged the industry growth. However, high cost of allogenic stem cell therapy may hamper the industry growth to some extent.

Market Segmentation, Outlook & Regional Insights: Stem Cell Therapy Market

Stem Cell Therapy Market, By Type

Allogenic stem cell therapy segment held around 39% revenue share in 2018 and it is anticipated to grow substantially during the analysis timeframe. Allogenic stem cell is available as off the shelf therapy and it is easily scalable that helps in providing treatment without delay. Moreover, the procedure includes culturing donor-derived immunocompetent cells that are highly effective in treatment of several diseases. Stem cells obtained in allogenic therapy are free of contaminating tumor cells. This reduces risk for disease recurrence that will surge its demand thereby, stimulating segment growth.

Autologous stem cell therapy segment is estimated to witness 10.1% growth over the forthcoming years. People usually prefer autologous stem cell therapy as it has minimum risk of immunological rejection. However, on introduction of allogenic stem cell therapy, demand for autologous stem cell therapy has declined as it is difficult to scale up. However, there are concerns regarding risk of cross contamination during large scale manufacturing of autologous stem cell lines that will impede segmental growth to some extent.

Stem Cell Therapy Market, By Application

The neurology segment was valued at around USD 1.6 billion in 2018 and it is estimated that it will witness significant growth over the forthcoming years. Stem cells are used to replenish the disrupted neurological cells that help in quick patient recovery. Pluripotent stem cells provide a replacement for cells and tissues to treat Alzheimers, Parkinsons disease, cerebral palsy, amyotrophic lateral sclerosis, and other neurodegenerative diseases. Thus, the pivotal role of stem cells in treating the life-threatening neurological condition will escalate segment growth.

The cardiovascular segment will witness 10% growth over the analysis timeframe. Considerable segmental growth can be attributed to development in stem cell therapies that have enhanced recovery pace in patients suffering from cardiovascular diseases. Recently developed allogeneic stem cell therapies are efficient and easily available that have reduced the mortality rates in cardiovascular patients. Above mentioned factors will propel cardiovascular segment growth in near future.

Stem Cell Therapy Market, By End-users

The hospital segment held over 56% revenue share in 2018 and it is anticipated to grow significantly in near future. The rising preference for stem cell therapies offered by hospitals proves beneficial for business growth. Hospitals have affiliations with research laboratories and academic institutes that carry out research activities for developing stem cell therapies. On the introduction and approval of any novel stem therapy, hospitals implement it immediately. Associations with research and academic institutes further help hospitals to upgrade its stem cell treatment offerings that positively impact the segmental growth.

The clinics segment is expected to grow at around 10% during the forecast timeframe. Clinics specializing in providing stem cell therapies are well-equipped with advanced medical devices and superior quality reagents required for imparting stem cell therapies. However, as clinics offer specialized stem cell therapies, their treatment cost is much higher as compared to hospitals that may reduce its preference.

Stem Cell Therapy Market, By Region

North America stem cell therapy market held around 41.5% revenue share in 2018 and it is estimated to grow substantially in near future. Increasing the adoption of novel stem cell therapies will prove beneficial for regional market growth. Moreover, favorable government initiatives have a positive impact on regional market growth. For instance, the government of Canada has initiated Strategic Innovation Fund Program that invests in research activities carried out for stem cell therapies enabling development in stem cell therapy. Above mentioned factors are expected to drive the North America market growth.

Asia Pacific stem cell therapy market is anticipated to witness 10.8% growth in the near future owing to increasing awareness amongst people pertaining to the benefits of advanced stem cell therapies. Additionally, favorable initiatives undertaken by several organizations will promote industry players to come up with innovative solutions. For instance, according to Pharma Focus Asia, members of the Asia-Pacific Economic Cooperation collaborated with Life Sciences Innovation Forum to involve professionals having expertise in stem cell therapies from academia and research centers to promote developments in stem cell research. Thus, growing initiatives by organizations ensuring the availability of new stem cell therapies will foster regional market growth.

Latin America Stem Cell Therapy Market Size, By Country, 2025 (USD Million)

Key Players, Recent Developments & Sector Viewpoints: Stem Cell Therapy Market

Key industry players in the stem cell therapy market include Astellas Pharma Inc, Cellectis, Celyad, Novadip Biosciences, Gamida Cell, Capricor Therapeutics, Cellular Dynamics, CESCA Therapeutics, DiscGenics, OxStem, Mesoblast Ltd, ReNeuron Group, and Takeda Pharmaceuticals. Chief industry players implement several initiatives such as mergers and acquisitions to sustain market competition. Also, receiving approvals for stem cell therapy products from regulatory authorities fosters the companys growth. For instance, in March 2018, the European Commission approved Takedas Alofisel that is off-the-shelf stem cell therapy. Product approval will help the company to gain a competitive advantage and capture market share.

Stem Cell Therapy Industry Viewpoint

The stem cells industry can be traced back to the 1950s. In 1959 first animals were made by in-vitro fertilization by preserving the stem cells. Till 2000, research was being carried out on stem cells to study its therapeutic effect. In 2000, fund allocations were made to research on cells derived from aborted human fetuses. In the same year, scientists derived human embryonic stem cells from the inner cell mass of blastocytes. Later, in 2010, clinical trials for human embryonic stem cell-based therapy were initiated. As technology progressed, stem cell therapy for treating cancer was developed. However, due to ethical issues, the use of stem cells for curing diseases witnessed slow growth for a few years. But as the regulatory scenario changed, people started preferring stem cell therapies due to its better efficacy. Stem cell therapy is in the developing stage and has numerous growth opportunities in developing economies with a high prevalence of chronic diseases.

Key Industry Development

In September 2020, Takeda Pharmaceutical Company Limited announced the expansion of its cell therapy manufacturing capabilities with the opening of a new 24,000 square-foot R&D cell therapy manufacturing facility at its R&D headquarters in Boston, Massachusetts. The facility provides end-to-end research and development capabilities and will accelerate Takedas efforts to develop next-generation cell therapies, initially focused on oncology with the potential to expand into other therapeutic areas.

The R&D cell therapy manufacturing facility will produce cell therapies for clinical evaluation from discovery through pivotal Phase 2b trials. The current Good Manufacturing Practices (cGMP) facility is designed to meet all U.S., E.U., and Japanese regulatory requirements for cell therapy manufacturing to support Takeda clinical trials around the world.

The proximity and structure of Takedas cell therapy teams allow them to quickly apply what they learn across a diverse portfolio of next-generation cell therapies including CAR NKs, armored CAR-Ts, and gamma delta T cells. Insights gained in manufacturing and clinical development can be quickly shared across global research, manufacturing, and quality teams, a critical ability in their effort to deliver potentially transformative treatments to patients as fast as possible.

Takeda and MD Anderson are developing a potential best-in-class allogeneic cell therapy product (TAK-007), a Phase 1/2 CD19-targeted chimeric antigen receptor-directed natural killer (CAR-NK) cell therapy with the potential for off-the-shelf use being studied in patients with relapsed or refractory non-Hodgkins lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Two additional Phase 1 studies of Takeda cell therapy programs were also recently initiated: 19(T2)28z1xx CAR T cells (TAK-940), a next-generation CAR-T signaling domain developed in partnership with Memorial Sloan Kettering Cancer Center (MSK) to treat relapsed/refractory B-cell cancers, and a cytokine and chemokine armored CAR-T (TAK-102) developed in partnership with Noile-Immune Biotech to treat GPC3-expressing previously treated solid tumors.

Takedas Cell Therapy Translational Engine (CTTE) connects clinical translational science, product design, development, and manufacturing through each phase of research, development, and commercialization. It provides bioengineering, chemistry, manufacturing, and control (CMC), data management, analytical, and clinical and translational capabilities in a single footprint to overcome many of the manufacturing challenges experienced in cell therapy development.

Key Insights Covered: Exhaustive Stem Cell Therapy Market

1. Market size (sales, revenue and growth rate) of Stem Cell Therapy industry.

2. Global major manufacturers operating situation (sales, revenue, growth rate and gross margin) of Stem Cell Therapy industry.

3. SWOT analysis, New Project Investment Feasibility Analysis, Upstream raw materials and manufacturing equipment & Industry chain analysis of Stem Cell Therapy industry.

4. Market size (sales, revenue) forecast by regions and countries from 2019 to 2025 of Stem Cell Therapy industry.

Research Methodology: Stem Cell Therapy Market

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Stem Cell Therapy Market Research Report Forecast to 2029 (Includes Business Impact of COVID-19) - Cheshire Media

Stem Cell Assay Market Overview, Development by Companies and Comparative Analysis by 2026 – Cheshire Media

The research study of the global Stem Cell Assay market provides the market size information and market trends along with the factors and parameters impacting it in both the short and long term. The report ensures a 360-degree assessment, bringing out the complete key insights of the industry. These insights help the business decision-makers to make better business plans and informed decisions for the future business. In addition, the study helps the venture capitalist in understanding the companies better and take informed decisions.

The Stem Cell Assay market research report provides essential statistics on the market position of the Stem Cell Assay manufacturers and is a valuable source of guidance and direction for companies and individuals interested in the industry. The report provides a basic summary of theStem Cell Assay industry including its definition, applications and manufacturing technology. The report presents the company profile, product specifications, capacity, production value, and market shares for key vendors.

The overall market is split by the company, by country, and by application/type for the competitive landscape analysis. The report estimates market development trends of Stem Cell Assay industry. Analysis of upstream raw materials, downstream demand and current market dynamics is also carried out. The Stem Cell Assay market report makes some important proposals for a new project of Stem Cell Assay Industry before evaluating its feasibility.

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Key segments covered in Stem Cell Assay market report: Major key companies, product type segment, end use/application segment and geography segment.

The information for each competitor includes:

Company segment, the report includes global key players of Stem Cell Assay as well as some small players:

For product type segment, this report listed the main product type of Stem Cell Assay market

For end use/application segment, this report focuses on the status and outlook for key applications. End users are also listed.

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This report covers the following regions:

Key Questions Answered in the Report:

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Stem Cell Assay Market Overview, Development by Companies and Comparative Analysis by 2026 - Cheshire Media

Precision BioSciences Reports Positive Interim Results from PBCAR0191 Phase 1/2a Trial in Relapsed/Refractory (R/R) Non-Hodgkin Lymphoma (NHL) and R/R…

DURHAM, N.C., Dec. 04, 2020 (GLOBE NEWSWIRE) -- Precision BioSciences Inc. (Nasdaq: DTIL) a clinical stage biotechnology company dedicated to improving life with its novel and proprietary ARCUS genome editing platform, today announced positive interim clinical results from its Phase 1/2a study of PBCAR0191, the Companys off-the-shelf allogeneic CAR T cell therapy investigational candidate targeting CD19. As of the November 16, 2020 cutoff, 27 patients including 16 patients with aggressive NHL and 11 patients with aggressive B-ALL were enrolled and evaluated.

Were very proud to share the latest update to our PBCAR0191 study. PBCAR0191, when combined with enhanced lymphodepletion resulted in a high objective response rate of 83% across enrolled NHL and B-ALL patients including those that previously received autologous CAR T therapy or stem cell transplants, said Matt Kane, CEO and Co-Founder of Precision BioSciences. We believe that this data set represents an important and meaningful step forward in the development of allogeneic CAR T therapies and establishes Precision BioSciences as a leader in the field.

I am extremely encouraged by what we have observed in this Phase I clinical trial of PBCAR0191. The data answered multiple questions associated with allogeneic cell therapies, including having seen no cases of GvHD. In the enhanced lymphodepletion arm, we observed the highest complete response rate seen to date in R/R aggressive NHL with an allogeneic product, said Bijal Shah, M.D., Associate Professor, Malignant Hematology Department, H. Lee Moffitt Cancer Center and Research Institute. As a result, I am encouraged that the interim data from the PBCAR0191 Phase 1 trial is a meaningful step toward the goal of an off-the-shelf CAR T product that could help patients immediately, when they need it most.

Trial Design Interim data from the Phase 1/2a study of PBCAR0191 includes data from 27 patients: 16 patients with R/R NHL and 11 patients with R/R B-ALL from multiple dose levels. In the NHL cohort, 100% of patients had aggressive lymphomas, 81% had stage III/IV disease, 63% had four or more courses of prior treatment and 25% had prior autologous CAR T. In the B-ALL cohort, 55% of patients had >20% blasts burden at baseline, 82% had 4+ courses of prior treatment and 45% had prior allogeneic stem cell transplant.

PBCAR0191 treatment at dose level (DL) 1 (3x105 cells), DL2 (1x106 cells), DL3 (3x106 cells) and split dose DL4 (2 doses at 3x106 cells) employed a single standard lymphodepletion (sLD) consisting of fludarabine (30 mg/m2/day for 3 days) plus cyclophosphamide (500 mg/m2/day for 3 days). PBCAR0191 was also dosed in an Enhanced Lymphodepletion Regimen consisting of PBCAR0191 cells at DL3 (n=5) or DL4 (n=1) plus fludarabine (30 mg/m2/day for 4 days) and cyclophosphamide (1000 mg/m2/day for 3 days).

For this study, in which patients received either sLD or eLD, response rates across R/R NHL and R/R B-ALL patient cohorts were as follows:

PBCAR0191, which incorporates Precisions patented N6 co-stimulatory domain, demonstrated a clear dose dependent increase in peak cell expansion. Compared to sLD, eLD with PBCAR0191 at DL3 resulted in approximately 95-fold increase in peak cell expansion, and approximately 45-fold increase in area under the curve. This was associated with a higher complete response rate in NHL (75%).

Safety and Tolerability In this dose escalation and dose expansion study, PBCAR0191 had an acceptable safety profile with no cases of GvHD, no cases of Grade 3 CRS, and no cases of Grade 3 ICANS.

One NHL patient who was treated with PBCAR0191 and eLD had previously received nine prior lines of therapy before entering the trial. The patient presented with persistent cytopenias at baseline and a history of infections, including bacterial sepsis. The patient had an episode of sepsis at day 27 which appeared to have resolved at day 33, following which a partial response was achieved at day 34. Unfortunately, the patient died at day 42 with grade 5 sepsis.

We are rapidly leveraging learnings from this study and enrolling more patients into our enhance lymphodepletion regimen. In parallel, we continue to evaluate higher cell doses, repeat dosing and other novel methods to further optimize our dosing strategy, said Chris Heery, Chief Medical Officer at Precision BioSciences. We also plan to pursue clinical development of PBCAR19B, our CD19 Stealth Cell candidate, which has shown to delay both T cell and natural killer cell mediated allogeneic rejection in vitro. We believe this is likely to result in improved persistence of allogeneic CAR T cells. We expect to move PBCAR19B into the clinic in 2021.

Company-Hosted Conference Call and Web Cast Information Precision will host a conference call and webcast today, December 4, 2020 at 8:00 a.m. ET to discuss the updated interim clinical data and the learnings for PBCAR0191 from both the NHL and B-ALL cohorts of this trial, as well as PBCAR19B. The dial-in conference call numbers for domestic and international callers are (866) 996-7202 and (270) 215-9609, respectively. The conference ID number for the call is 6368255. Participants may access the live webcast and the accompanying presentation materials on Precisions website https://investor.precisionbiosciences.com/events-and-presentations in the Investors and Media section under Events and Presentations. An archived replay of the webcast will be available on Precisions website.

About Precision BioSciences, Inc. Precision BioSciences, Inc. is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS genome editing platform. ARCUS is a highly specific and versatile genome editing platform that was designed with therapeutic safety, delivery, and control in mind. Using ARCUS, the Companys pipeline consists of multiple off-the-shelf CAR T immunotherapy clinical candidates and several in vivo gene correction therapy candidates to cure genetic and infectious diseases where no adequate treatments exist. For more information about Precision BioSciences, please visit http://www.precisionbiosciences.com.

About PBCAR0191 PBCAR0191 is an investigational allogeneic chimeric antigen receptor T cell therapy (CAR T) in Phase 1/2a trials for the treatment of patients with R/R NHL and R/R B-ALL. PBCAR0191 was designed using Precision BioSciences novel and proprietary ARCUS genome editing platform. It has been granted Fast Track Designation by the FDA for B-ALL. Precision also holds Orphan Drug Designation from the FDA for this program in mantle cell lymphoma, an aggressive subtype of NHL. PBCAR0191 is being developed in collaboration with Servier.

About Precisions Collaboration with Servier Under the terms of the agreement with Servier, Precision is solely responsible for early-stage research activities as well as PBCAR0191 Phase 1/2a clinical trial execution and clinical supply. Servier has the exclusive right to opt in for late-stage development and commercialization, and Precision has the right to participate in the development and commercialization of any licensed products resulting from the collaboration through a 50/50 co-development and co-promotion option in the United States.

Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the expected timing of clinical updates and interim data reports related to PBCAR0191 and the commencement of clinical studies for PBCAR19B. In some cases, you can identify forward-looking statements by terms such as aim, anticipate, believe, could, expect, should, plan, intend, estimate, target, mission, goal, may, will, would, should, could, target, potential, project, predict, contemplate, potential, or the negative thereof and similar words and expressions.

Forward-looking statements are based on managements current expectations, beliefs and assumptions and on information currently available to us. Such statements are subject to a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to: our ability to become profitable; our ability to procure sufficient funding and requirements under our current debt instruments and effects of restrictions thereunder; risks associated with raising additional capital; our operating expenses and our ability to predict what those expenses will be; our limited operating history; the success of our programs and product candidates in which we expend our resources; our limited ability or inability to assess the safety and efficacy of our product candidates; our dependence on our ARCUS technology; the initiation, cost, timing, progress, achievement of milestones and results of research and development activities, preclinical or greenhouse studies and clinical or field trials; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, biotechnology and agricultural biotechnology fields; our or our collaborators ability to identify, develop and commercialize product candidates; pending and potential liability lawsuits and penalties against us or our collaborators related to our technology and our product candidates; the U.S. and foreign regulatory landscape applicable to our and our collaborators development of product candidates; our or our collaborators ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; our or our collaborators ability to advance product candidates into, and successfully design, implement and complete, clinical or field trials; potential manufacturing problems associated with the development or commercialization of any of our product candidates; our ability to obtain an adequate supply of T cells from qualified donors; our ability to achieve our anticipated operating efficiencies at our manufacturing facility; delays or difficulties in our and our collaborators ability to enroll patients; changes in interim top-line and initial data that we announce or publish; if our product candidates do not work as intended or cause undesirable side effects; risks associated with applicable healthcare, data protection, privacy and security regulations and our compliance therewith; the rate and degree of market acceptance of any of our product candidates; the success of our existing collaboration agreements, and our ability to enter into new collaboration arrangements; our current and future relationships with and reliance on third parties including suppliers and manufacturers; our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates; potential litigation relating to infringement or misappropriation of intellectual property rights; our ability to effectively manage the growth of our operations; our ability to attract, retain, and motivate key executives and personnel; market and economic conditions; effects of system failures and security breaches; effects of natural and manmade disasters, public health emergencies and other natural catastrophic events effects of the outbreak of COVID-19, or any pandemic, epidemic or outbreak of an infectious disease; insurance expenses and exposure to uninsured liabilities; effects of tax rules; risks related to ownership of our common stock and other important factors discussed under the caption Risk Factors in our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020, as any such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SECs website at http://www.sec.gov and the Investors & Media page of our website at investor.precisionbiosciences.com.

All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, we have no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Investor Contact: Alex Kelly Chief Corporate Affairs Officer Alex.Kelly@precisionbiosciences.com

Media Contact: Maurissa Messier Senior Director, Corporate Communications Maurissa.Messier@precisionbiosciences.com

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Precision BioSciences Reports Positive Interim Results from PBCAR0191 Phase 1/2a Trial in Relapsed/Refractory (R/R) Non-Hodgkin Lymphoma (NHL) and R/R...

Cancer center is a contributor to 49 research studies at the 62nd American Society of Hematology Annual Meeting – Newswise

Newswise Researchers from The University of Kansas Cancer Center are involved in the presentation of nearly 50 research studies at the 62ndAmerican Society of Hematology (ASH) Annual Meeting, to be held virtually Dec. 5-8 because of the COVID-19 pandemic. With more than 18,000 members from nearly 100 countries, the ASH is the world's largest professional society serving both clinicians and scientists around the world who are working to conquer blood diseases.

The KU Cancer Center is one of only 71 cancer centers designated by the National Cancer Institute because they meet rigorous standards for transdisciplinary, state-of-the-art research focused on developing new and better approaches to preventing, diagnosing and treating cancer. Its catchment area includes the state of Kansas as well as western Missouri.

These 49 research studies represent the hard work of our many researchers focused on blood diseases, said Roy Jensen, M.D., director of the KU Cancer Center. This includes innovations in immunotherapy, advances in leukemia and significant work in stem cell transplants. While the conference is virtual this year, the KU Cancer Center will be well represented.

While a full list of abstracts involving KU Cancer Center researchers can be found online, three of the most significant are listed below.

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About The University of Kansas Cancer Center:

The University of Kansas Cancer Center is transforming cancer research and clinical care by linking an innovative approach to drug discovery, delivery and development to a nationally-accredited patient care program. Our consortium center includes cancer research and health care professionals associated with the University of Kansas Medical Center and The University of Kansas Health System; the University of Kansas, Lawrence; The Stowers Institute for Medical Research; Childrens Mercy; and in partnership with members of the Masonic Cancer Alliance.

About the University of Kansas Medical Center:

The University of Kansas Medical Centers mission is to educate exceptional health care professionals through a full range of undergraduate, graduate, professional, postdoctoral and continuing education programs in the schools of Medicine, Nursing and Health Professions. KU Medical Center also advances the health sciences through world-class research programs; provides compassionate and state-of-the-art patient care in an academic medical center environment; and works with communities in every Kansas county to improve the health of Kansans.

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Cancer center is a contributor to 49 research studies at the 62nd American Society of Hematology Annual Meeting - Newswise