Stem Cell Clinic

Gene therapy research for HIV awarded $14.6 million NIH grant – USC News

Paula Cannon. (USC Photo/Richard Carrasco)

An HIV research program led by scientists at USC and the Fred Hutchinson Cancer Research Center in Seattle has received a five-year, $14.6million grant from the National Institutes of Health. The team is advancing a gene therapy approach to control the virus without the need for daily medicines.

The programs co-directors are Paula Cannon, PhD, Distinguished Professor of Molecular Microbiology and Immunology at the Keck School of Medicine of USC, and Hans-Peter Kiem, MD, PhD, the Stephanus Family Endowed Chair for Cell and Gene Therapy at Fred Hutch. Other key partners are David Scadden, MD, a professor at Harvard University, and the biotechnology company Magenta Therapeutics.

The NIH award will support preclinical studies that combine gene editing against HIV with technologies for safer and more effective hematopoietic stem cell transplants. Such transplants, also known as bone marrow transplants, are currently used for severe blood cancers. They renew a patients immune system, which can be damaged by cancer therapies, by infusing healthy donor blood stem cells that can grow into any type of blood or immune cell.

The researchers goal is to build a therapy that prepares patients for a stem cell transplantation using their own cells with little to no toxicity, engineers their own stem cells to fight HIV and stimulates those cells to quickly produce new and engineered immune cells once theyre reintroduced into the patient.

This grant funds a team with an overarching goal of developing what our perfect HIV gene therapy would look like, Cannon said. All of these pieces could happen separately, but the fact that the NIH has funded us as a team means that the sum will be so much bigger than the parts.

Halting HIV without daily drugs

About 38million people worldwide are living with HIV, the virus that causes AIDS. HIV is manageable with daily antiretroviral drugs, but the research team seeks a more durable solution.

Their strategy is inspired by the three cases where patients seem to have been cured of HIV. All had aggressive leukemia and received blood stem cell transplants from donors who also carried a mutation that confers immunity to HIV. The mutation was in the CCR5 gene, which encodes a receptor that HIV uses to infect immune cells and is present in about 1 percent of the population.

Timothy Ray Brown, famously nicknamed the Berlin patient, received such a transplant in 2007; he has been off antiretroviral drugs since then, and the virus remains undetectable in his system. In recent years, patients in London and Dusseldorf have shown similar results.

I think of the Berlin patient as proof of principle that replacing the immune system with one thats HIV-resistant by removing CCR5 is a possible way to treat somebody, Cannon said.

However, the rigors of the blood stem cell transplant process, combined with the difficulty in finding tissue-matched CCR5-negative donors, make it highly unlikely that this will provide more than a very rare treatment.

Three for one gene therapy

The research team will tackle these two major problems. First, to get around the lack of CCR5-negative donors, Cannon has already helped pioneer the use of gene editing to remove CCR5 from a patients own stem cells. This is now an investigational treatment for HIV in a clinical trial at City of Hope in Duarte, California.

She will now combine CCR5 disruption with additional genetic changes, so that the progeny of engineered stem cells will release antibodies and antibody-like molecules that block HIV.

Our engineered cells will be good neighbors, Cannon said. They secrete these protective molecules so that other cells, even if they arent engineered to be CCR5-negative, have some chance of being protected.

Meanwhile, Kiems group is providing a third approach by adapting an emerging cancer treatment called CAR T cell therapy. This re-engineers T cells of the immune system with chimeric antigen receptors (CARs), which are customized to recognize cancer cells.

In this project, Kiem and colleagues will create stem cells whose T cell descendants can instead hunt down HIV-infected cells.

A gentler blood stem cell transplant

The grant also supports two other components that relate to the blood stem cell transplant.

Magenta Therapeutics is developing less-toxic protocols for conditioningpreparing a patients bone marrow to receive a transplant. Traditionally, mild chemotherapy or radiotherapy is needed to make room for newly infused stem cells and to help them re-engraft.

The company is instead using antibody-drug conjugates to deliver this conditioning much more narrowly and to reduce the side effects that occur with systemic chemo or radiation.

Meanwhile, Scadden and his team are addressing another drawback of stem cell transplants and conditioning, the delay before infused stem cells generate new immune cells in sufficient numbers. In cancer patients, this delay leaves them highly susceptible to infection.

Scadden is approaching this using an injectable gel that biochemically resembles the bone marrow environment, to quickly repopulate the immune system with HIV-fighting cells.

With success, the teams research may free HIV patients from the need for daily medication and the expense and potential side effects that come with it. Their work may also improve other therapies based on blood stem cells, for conditions such as cancer, sickle cell disease and autoimmune disorders.

A home run would be that we completely cure people of HIV, Cannon said. What Id be fine with is the idea that somebody no longer needs to take anti-HIV drugs every day because their immune system is keeping the virus under control, so that it no longer causes health problems and, importantly, they cant transmit it to anybody else.

By Wayne Lewis

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Gene therapy research for HIV awarded $14.6 million NIH grant - USC News

Making Headway in the Quest for COVID-19 Cell Therapies – Technology Networks

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With the SARS-CoV-2 virus now widespread around the globe, scientists across many disciplines are racing to develop therapies for COVID-19 a disease which has disrupted our world. Vaccine research continues, and a wide range of potential treatments are being explored, including the repurposing of small molecules and de novo design of drugs and peptides. Interest in cell-based therapies has escalated over recent decades, largely driven by a growing appreciation for the inter-individual variation that exists for many diseases and the subsequent shift towards personalized medicine. This trend has been supported by increasing technical and manufacturing capabilities and has continued in 2020. In June, a director from the US Food and Drug Administration (FDA) said their clinical team was stretched trying to deal with the COVID-19-related growth. In the same month there were more than 1000 cell therapies in the pipeline, 25 of which were available in the market. Increasing commercial investment suggests expectations of the industry are high, and it is hoped cell therapies will be available to treat a wide range of diseases in the near future. Faced with a global pandemic, we explore the following questions: can cell therapies help alleviate the symptoms of COVID-19? What strategies are being employed?

Table 1. Examples and rationale of cell therapy approaches for COVID-19

Michele Wilson is a freelance science writer for Choice Science Writing.

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Making Headway in the Quest for COVID-19 Cell Therapies - Technology Networks

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

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

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

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

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

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

Cord Blood Industry Trends

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

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

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

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

Cord Blood Expansion Technologies

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

Key strategies being explored for this purpose include:

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

Cord Blood Banking by Region

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

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

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

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

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

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

1. Number of cord blood units cryopreserved in public and private cord blood banks globally 2. Number of hematopoietic stem cell transplants (HSCTs) globally using cord blood cells 3. Utilization of cord blood cells in clinical trials for developing regenerative medicines 4. The decline of the utilization of cord blood cells in HSC transplantations since 2005 5. Emerging technologies to influence the financial sustainability of public cord blood banks 6. The future scope for companion products from cord blood 7. The changing landscape of cord blood cell banking market 8. Extension of services by cord blood banks 9. Types of cord blood banks 10. The economic model of public cord blood banks 11. Cost analysis for public cord blood banks 12. The economic model of private cord blood banks 13. Cost analysis for private cord blood banks 14. Profit margins for private cord blood banks 15. Pricing for processing and storage in private banks 16. Rate per cord blood unit in the U.S. and Europe 17. Indications for the use of cord blood-derived HSCs for transplantations 18. Diseases targeted by cord blood-derived MSCs in regenerative medicine 19. Cord blood processing technologies 20. Number of clinical trials, number of published scientific papers and NIH funding for cord blood research 21. Transplantation data from different cord blood registries

Key questions answered in this report are:

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

Key Topics Covered

1. REPORT OVERVIEW 1.1 Statement of the Report 1.2 Executive Summary 1.3 Introduction 1.3.1 Cord Blood: An Alternative Source for HPSCs 1.3.2 Utilization of Cord Blood Cells in Clinical Trials 1.3.3 The Struggle of Cord Blood Banks 1.3.4 Emerging Technologies to Influence Financial Sustainability of Banks 1.3.4.1 Other Opportunities to Improve Financial Stability 1.3.4.2 Scope for Companion Products 1.3.5 Changing Landscape of Cord Blood Cell Banking Market 1.3.6 Extension of Services by Cord Blood Banks

2. CORD BLOOD & CORD BLOOD BANKING: AN OVERVIEW 2.1 Cord Blood Banking (Stem Cell Banking) 2.1.1 Public Cord Blood Banks 2.1.1.1 Economic Model of Public Cord Blood Banks 2.1.1.2 Cost Analysis for Public Banks 2.1.1.3 Relationship between Costs and Release Rates 2.1.2 Private Cord Blood Banks 2.1.2.1 Cost Analysis for Private Cord Blood Banks 2.1.2.2 Economic Model of Private Banks 2.1.3 Hybrid Cord Blood Banks 2.2 Globally Known Cord Blood Banks 2.2.1 Comparing Cord Blood Banks 2.2.2 Cord Blood Banks in the U.S. 2.2.3 Proportion of Public, Private and Hybrid Banks 2.3 Percent Share of Parents of Newborns Storing Cord Blood by Country/Region 2.4 Pricing for Processing and Storage in Commercial Banks 2.4.1 Rate per Cord Blood Unit in the U.S. and Europe 2.5 Cord Blood Revenues for Major Cord Blood Banks

3. CORD BLOOD BANK ACCREDITATIONS 3.1 American Association of Blood Banks (AABB) 3.2 Foundation for the Accreditation of Cellular Therapy (FACT) 3.3 FDA Registration 3.4 FDA Biologics License Application (BLA) License 3.5 Investigational New Drug (IND) for Cord Blood 3.6 Human Tissue Authority (HTA) 3.7 Therapeutic Goods Act (TGA) in Australia 3.8 International NetCord Foundation 3.9 AABB Accredited Cord Blood Facilities 3.10 FACT Accreditation for Cord Blood Banks

4. APPLICATIONS OF CORD BLOOD CELLS 4.1 Hematopoietic Stem Cell Transplantations with Cord Blood Cells 4.2 Cord Cells in Regenerative Medicine

5. CORD BLOOD PROCESSING TECHNOLOGIES 5.1 The Process of Separation 5.1.1 PrepaCyte-CB 5.1.2 Advantages of PrepaCyte-CB 5.1.3 Treatment Outcomes with PrepaCyte-CB 5.1.4 Hetastarch (HES) 5.1.5 AutoXpress (AXP) 5.1.6 SEPAX 5.1.7 Plasma Depletion Method (MaxCell Process) 5.1.8 Density Gradient Method 5.2 Comparative Merits of Different Processing Methods 5.2.1 Early Stage HSC Recovery by Technologies 5.2.2 Mid Stage HSC (CD34+/CD133+) Recovery from Cord Blood 5.2.3 Late Stage Recovery of HSCs from Cord Blood 5.3 HSC (CD45+) Recovery 5.4 Days to Neutrophil Engraftment by Technology 5.5 Anticoagulants used in Cord Blood Processing 5.5.1 Type of Anticoagulant and Cell Recovery Volume 5.5.2 Percent Cell Recovery by Sample Size 5.5.3 TNC Viability by Time Taken for Transport and Type of Anticoagulant 5.6 Cryopreservation of Cord Blood Cells 5.7 Bioprocessing of Umbilical Cord Tissue (UCT) 5.8 A Proposal to Improve the Utilization Rate of Banked Cord Blood

6. CORD BLOOD CLINICAL TRIALS, SCIENTIFIC PUBLICATIONS & NIH FUNDING 6.1 Cord Blood Cells for Research 6.2 Cord Blood Cells for Clinical Trials 6.2.1 Number of Clinical Trials involving Cord Blood Cells 6.2.2 Number of Clinical Trials using Cord Blood Cells by Geography 6.2.3 Number of Clinical Trials by Study Type 6.2.4 Number of Clinical Trials by Study Phase 6.2.5 Number of Clinical Trials by Funder Type 6.2.6 Clinical Trials Addressing Indications in Children 6.2.7 Select Three Clinical Trials Involving Children 6.2.7.1 Sensorineural Hearing Loss (NCT02038972) 6.2.7.2 Autism Spectrum (NCT02847182) 6.2.7.3 Cerebral Palsy (NCT01147653) 6.2.8 Clinical Trials for Neurological Diseases using Cord Blood and Cord Tissue 6.2.9 UCB for Diabetes 6.2.10 UCB in Cardiovascular Clinical Trials 6.2.11 Cord Blood Cells for Auto-Immune Diseases in Clinical Trials 6.2.12 Cord Tissue Cells for Orthopedic Disorders in Clinical Trials 6.2.13 Cord Blood Cells for Other Indications in Clinical Trials 6.3 Major Diseases Addressed by Cord Blood Cells in Clinical Trials 6.4 Clinical Trials using Cord Tissue-Derived MSCs 6.5 Ongoing Clinical Trials using Cord Tissue 6.5.1 Cord Tissue-Based Clinical Trials by Geography 6.5.2 Cord Tissue-Based Clinical Trials by Phase 6.5.3 Cord Tissue-Based Clinical Trials by Sponsor Types 6.5.4 Companies Sponsoring in Trials using Cord Tissue-Derived MSCs 6.6 Wharton's Jelly-Derived MSCs in Clinical Trials 6.6.1 Wharton's Jelly-Based Clinical Trials by Phase 6.6.2 Companies Sponsoring Wharton's Jelly-Based Clinical Trials 6.7 Clinical Trials Involving Cord Blood Expansion Studies 6.7.1 Safe and Feasible Expansion Protocols 6.7.2 List of Clinical Trials involved in the Expansion of Cord Blood HSCs 6.7.3 Expansion Technologies 6.8 Scientific Publications on Cord Blood 6.9 Scientific Publications on Cord Tissue 6.10 Scientific Publications on Wharton's Jelly-Derived MSCs 6.11 Published Scientific Papers on Cord Blood Cell Expansion 6.12 NIH Funding for Cord Blood Research

7. PARENT'S AWARENESS AND ATTITUDE TOWARDS CORD BLOOD BANKING 7.1 Undecided Expectant Parents 7.2 The Familiar Cord Blood Banks Known by the Expectant Parents 7.3 Factors Influencing the Choice of a Cord Blood Bank

8. CORD BLOOD: AS A TRANSPLANTATION MEDICINE 8.1 Comparisons of Cord Blood to other Allograft Sources 8.1.1 Major Indications for HCTs in the U.S. 8.1.2 Trend in Allogeneic HCT in the U.S. by Recipient Age 8.1.3 Trends in Autologous HCT in the U.S. by Recipient Age 8.2 HCTs by Cell Source in Adult Patients 8.2.1 Transplants by Cell Source in Pediatric Patients 8.3 Allogeneic HCTs by Cell Source 8.3.1 Unrelated Donor Allogeneic HCTs in Patients &lessThan;18 Years 8.4 Likelihood of Finding an Unrelated Cord Blood Unit by Ethnicity 8.4.1 Likelihood of Finding an Unrelated Cord Blood Unit for Patients &lessThan;20 Years 8.5 Odds of using a Baby's Cord Blood 8.6 Cord Blood Utilization Trends 8.7 Number of Cord Blood Donors Worldwide 8.7.1 Number of CBUs Stored Worldwide 8.7.2 Cord Blood Donors by Geography 8.7.2.1 Cord Blood Units Stored in Different Geographies 8.7.2.2 Number of Donors by HLA Typing 8.7.3 Searches Made by Transplant Patients for Donors/CBUs 8.7.4 Types of CBU Shipments (Single/Double/Multi) 8.7.5 TNC Count of CBUs Shipped for Children and Adult Patients 8.7.6 Shipment of Multiple CBUs 8.7.7 Percent Supply of CBUs for National and International Patients 8.7.8 Decreasing Number of CBU Utilization 8.8 Top Ten Countries in Cord Blood Donation 8.8.1 HLA Typed CBUs by Continent 8.8.2 Percentage TNC of Banked CBUs 8.8.3 Total Number of CBUs, HLA-Typed Units by Country 8.9 Cord Blood Export/Import by the E.U. Member States 8.9.1 Number of Donors and CBUs in Europe 8.9.2 Number of Exports/Imports of CBUs in E.U. 8.10 Global Exchange of Cord Blood Units

9. CORD BLOOD CELLS AS THERAPEUTIC CELL PRODUCTS IN CELL THERAPY 9.1 MSCs from Cord Blood and Cord Tissue 9.1.1 Potential Neurological Applications of Cord Blood-Derived Cells 9.1.2 Cord Tissue-Derived MSCs for Therapeutic use 9.1.2.1 Indications Targeted by UCT-MSCs in Clinical Trials 9.2 Current Consumption of Cord Blood Units by Clinical Trials 9.3 Select Cord Blood Stem Cell Treatments in Clinical Trials 9.3.1 Acquired Hearing Loss (NCT02038972) 9.3.2 Autism (NCT02847182) 9.3.3 Cerebral Palsy (NCT03087110) 9.3.4 Hypoplastic Left Heart Syndrome (NCT01856049) 9.3.5 Type 1 Diabetes (NCT00989547) 9.3.6 Psoriasis (NCT03765957) 9.3.7 Parkinson's Disease (NCT03550183) 9.3.8 Signs of Aging (NCT04174898) 9.3.9 Stroke (NCT02433509) 9.3.10 Traumatic Brain Injury (NCT01451528)

10. MARKET ANALYSIS 10.1 Public vs. Private Cord Blood Banking Market 10.2 Cord Blood Banking Market by Indication

11. PROFILES OF SELECT CORD BLOOD BANKS 11.1 AllCells 11.1.1 Whole Blood 11.1.2 Leukopak 11.1.3 Mobilized Leukopak 11.1.4 Bone Marrow 11.1.5 Cord Blood 11.2 AlphaCord LLC 11.2.1 NextGen Collection System 11.3 Americord Registry, Inc. 11.3.1 Cord Blood 2.0 11.3.2 Cord Tissue 11.3.3 Placental Tissue 2.0 11.4 Be The Match 11.4.1 Hub of Transplant Network 11.4.2 Partners of Be The Match 11.4.3 Allogeneic Cell Sources in Be The Match Registry 11.4.4 Likelihood of a Matched Donor on Be The Match by Ethnic Background 11.5 Biocell Center Corporation 11.5.1 Chorionic villi after Delivery 11.5.2 Amniotic Fluid and Chorionic Villi during Pregnancy 11.6 BioEden Group, Inc. 11.6.1 Differences between Tooth Cells and Umbilical Cord Cells 11.7 Biovault Family 11.7.1 Personalized Cord Blood Processing 11.8 Cell Care 11.9 Cells4Life Group, LLP 11.9.1 Cells4Life's pricing 11.9.2 TotiCyte Technology 11.9.3 Cord Blood Releases 11.10 Cell-Save 11.11 Center for International Blood and Marrow Transplant Research (CIBMTR) 11.11.1 Global Collaboration 11.11.2 Scientific Working Committees 11.11.3 Medicare Clinical Trials and Studies 11.11.4 Cellular Therapy 11.12 Crio-Cell International, Inc. 11.12.1 Advanced Collection Kit 11.12.2 Prepacyte-CB 11.12.3 Crio-Cell International's Pricing 11.12.4 Revenue for Crio-Cell International 11.13 Cord Blood Center Group 11.13.1 Cord Blood Units Released 11.14 Cordlife Group, Ltd. 11.14.1 Cordlife's Cord Blood Release Track Record 11.15 Core23 Biobank 11.16 Cord Blood Registry (CBR) 11.17 CordVida 11.18 Crioestaminal 11.18.1 Cord Blood Transplantation in Portugal 11.19 Cryo-Cell International, Inc. 11.19.1 Processing Method 11.19.2 Financial Results of the Company 11.20 CryoHoldco 11.21 Cryoviva Biotech Pvt. Ltd 11.22 European Society for Blood and Bone Marrow Transplantation (EBMT) 11.22.1 EBMT Transplant Activity 11.23 FamiCord Group 11.24 GeneCell International 11.25 Global Cord Blood Corporation 11.25.1 The Company's Business 11.26 HealthBaby Hong Kong 11.26.1 BioArchive System Service Plan 11.26.2 MVE Liquid Nitrogen System 11.27 HEMAFUND 11.28 Insception Lifebank 11.29 LifebankUSA 11.29.1 Placental Banking 11.30 LifeCell International Pvt. Ltd. 11.31 MiracleCord, Inc. 11.32 Maze Cord Blood Laboratories 11.33 New England Cord Blood Bank, Inc. 11.34 New York Cord Blood Center (NYBC) 11.34.1 Products 11.34.2 Laboratory Services 11.35 PacifiCord 11.35.1 FDA-Approved Sterile Collection Bags 11.35.2 AXP Processing System 11.35.3 BioArchive System 11.36 ReeLabs Pvt. Ltd. 11.37 Smart Cells International, Ltd. 11.38 Stem Cell Cryobank 11.39 StemCyte, Inc. 11.39.1 StemCyte Sponsored Clinical Trials 11.39.1.1 Spinal Cord Injury Phase II 11.39.1.2 Other Trials 11.40 Transcell Biolife 11.40.1 ScellCare 11.40.2 ToothScell 11.41 ViaCord 11.42 Vita 34 AG 11.43 World Marrow Donor Association (WMDA) 11.43.1 Search & Match Service 11.44 Worldwide Network for Blood & Marrow Transplantation (WBMT)

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

What is Wharton’s Jelly? – PRNewswire

CLEARWATER, Fla., Sept. 2, 2020 /PRNewswire/ --Wharton's jellyis at the forefront of current medical research. Its name dates back to the 17th century when the English anatomist Thomas Wharton first identified the jellylike substance that surrounds vital parts inside the umbilical cord. Today, it has become a distinct source of stem cells and, therefore, Advanced Medical Integration considers it a critical element in the advancement ofmedical treatments for everything from wound care to surgical procedures.

Found within Wharton's jellyare several distinct stem cell genes. With this raw material, biomedical firms can create stem cell lines that, among other things, aid recuperation via the regeneration of tissue that has been lost or damaged.

This is because stem cells are, basically, the core building blocks of all human cells. When retrieved from sources like Wharton's jelly, stem cells are not dedicated to any specific bodily function. But their power is that they have the ability, when introduced to other parts of the body, to adapt and grow into other, more "mature" types of cells (known as potency).

Stem cells are unspecialized cells of the human body. They are able to differentiate into any cell of an organism and have the ability of self-renewal. Stem cells exist both in embryos and adult cells. There are several steps of specialization.

Current research is focused on growing a wide range of new tissue from stem cells, including muscle, blood, brain, and cartilage cells. It is an intricate field with remarkable potential.

There are currently four ways of sourcing stem cells.Each is now a distinct area of study and research, with the relative strengths and weaknesses of each methodology being probed and perfected:

CONTACT:Stefen Anderson, Director of Marketing |[emailprotected]| 888-777-0815

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What is Wharton's Jelly? - PRNewswire

Optimized Freezing Solutions for Clinical Application of Cell Therapy Products – Technology Networks

AMSBIO has announced new additions and certifications for its range of clinical grade, chemically defined cryopreservation excipient solutions STEM-CELLBANKER and HSC-BANKER.

STEM-CELLBANKER DMSO Free GMP grade is a new chemically defined freezing solution that does not contain DMSO as an anti-freezing agent. It was developed for customers who prefer not to use DMSO-containing cryopreservation solution due to the intended application of the samples. STEM-CELLBANKER DMSO Free GMP grade is manufactured in compliance with JPN, EU, US, and PIC/S GMP guidelines.

STEM-CELLBANKER is a chemically defined freezing media optimized for stem cells and iPS cells storage, as well as fragile primary cells. Published data supports its ability to cryopreserve organoids and tissues to allow the recovery of viable cells. STEM-CELLBANKER GMP grade is manufactured in compliance with JPN, EU, US, and PIC/S GMP guidelines. Free from animal derived components this popular cryopreservation medium contains only chemically defined USP, EP and JP grade ingredients. Available in both DMSO containing and DMSO-Free formulations, STEM-CELLBANKER is an optimal freezing solution for basic research and is finding widespread use in the clinical application of cell therapy products.

Manufactured to be completely free of serum and animal derived components, HSC-BANKER contains only European or US Pharmacopoeia graded ingredients making it suitable for storage of hematopoietic stem cells developed for cell therapy applications.

Recently the master files of HSC-BANKER were accepted by the Center for Biologics Evaluation and Research (CBER) within the US FDA (Food and Drug Administration). Master files are submissions to the FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. Beneficially they allow researchers to reference material without disclosing Master file contents to those parties.

HSC-BANKER is supplied ready-to-use and requires no special devices, such as a controlled rate freezer, in order to achieve consistently high viabilities following resuscitation from cryopreservation, even over extended long-term storage. HSC-BANKER significantly increases cell viability while maintaining cell pluripotency, normal karyotype and proliferation ability after freeze-thaw. Evaluated for endotoxins, pH, osmolarity and mycoplasma contaminants to ensure GMP equivalent quality. HSC-BANKER is part of the CELLBANKER range of cryopreservation media for cells, organoids and tissues.

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Global Stem Cell Therapy Market: Shares, Strategies and Key Industry Players By 2025 – The Daily Chronicle

Global Stem Cell Therapy Market research report 2020 offers an expert and thorough analysis of the present condition alongside competitive scenario, Premium Messaging share and forecast by 2027. The report presents the fundamentals: definitions, characterizations, applications and Premium Messaging industry chain diagram; industry arrangements and plans; product type determinations; cost structures etc. It examines worlds leading countries according to their economic situations, including the Premium Messaging types advancement, benefits, demand and supply, industry development rate and so on. The report presented new undertaking SWOT and Premium Messaging PESTEL information, venture plausibility, and speculation return.

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The fundamental target of the Stem Cell Therapy Market report is to find out the market knowledge and help players to achieve development in their specific fields. Also, Premium Messaging report maintains a refreshed industry propensity of which includes the current market circumstances and market forecast amid 2020-2027. Additionally, the report centers on the market estimations of the worldwide Stem Cell Therapy Market. Further, the Premium Messaging report also grasps the type examination of the market details, openings in order to empower Stem Cell Therapy Market investors to take a fundamental choice on their future tasks.

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Broad information on the key players is shrouded in this Premium Messaging report. This incorporates Business outline, market share, offering, benefits, and methodologies of top players. Bottom-up assessment of the key organizations alongside their vital resources, for example, development, cost, and purchasers have been shrouded in the exploration give an account of the Worldwide Stem Cell Therapy Market.

Stem Cell Therapy Market Segmentation

Type Analysis of Stem Cell Therapy Market:

Based on cell source, the market has been segmented into,

Adipose Tissue-Derived Mesenchymal SCs Bone Marrow-Derived Mesenchymal SCs Embryonic SCs Other Sources

Applications Analysis of Stem Cell Therapy Market:

Based on therapeutic application, the market has been segmented into,

Musculoskeletal Disorders Wounds & Injuries Cardiovascular Diseases Gastrointestinal Diseases Immune System Diseases Other Applications

Regional Stem Cell Therapy Market on the basis of Development: 1. North America Stem Cell Therapy Market (United States, Mexico, Canada); 2. Europe Stem Cell Therapy Market (Germany, France, UK, Russia and Italy); 3. Asia-Pacific Stem Cell Therapy Market (China, Japan, Korea, India and Southeast Asia); 4. South America Stem Cell Therapy Market (Brazil, Argentina, Columbia etc); 5. Oceanian sub-region (New Zealand and Australia); 6. The Middle East and Africa Stem Cell Therapy Market (Saudi Arabia, UAE, Egypt, Nigeria, Brazil and South Africa);

Overview of the Market on the Basis of TOC:

Section 1: Definition, Determinations and Characterization of Premium Messaging, Utilizations, Various Segments by Leading Regions;

Section 2: Assembling Cost Structure, Materials and Providers, Premium Messaging Assembling Procedure, Market Chain Structure;

Section 3: Specialized Information of Premium Messaging, Circulation, Research and development Status and Innovation Source, Materials Sources Investigation;

Section 4: Global Market Analysis, Market Limitation (Organization Profiles), Organization Fragment, Premium Messaging Deals Value Examination (Various Segments);

Section 5 and 6: Global Stem Cell Therapy Market Examination that incorporates worldwide regions.

Section 7: The Premium Messaging Segments In-Depth Analysis by Application, by Types, Significant Players Examination;

Section 8: Regional Stem Cell Therapy Markets Pattern according to the Type Development and End Client Applications;

Section 9: Global Premium Messaging Trade, Inventory network data;

Section 10: The Premium Messaging Buyer and Consumer Analysis;

Section 11: Reference section, technique and information source, Premium Messaging deals channel;

Section 12, 13 and 14: Premium Messaging Exploration Discoveries and Conclusion.

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Global Stem Cell Therapy Market: Shares, Strategies and Key Industry Players By 2025 - The Daily Chronicle

Cartesian Therapeutics Initiates Clinical Trial of First RNA-Engineered Cell Therapy for Acute Respiratory Distress Syndrome and COVID-19 – PRNewswire

GAITHERSBURG, Md., Sept. 1, 2020 /PRNewswire/ --Cartesian Therapeutics, a fully integrated, clinical-stage biopharmaceutical company developing cell and gene therapies for cancer, autoimmune diseases and respiratory diseases, today announced that it has initiated a Phase 1/2 clinical trial of its lead RNA-engineered mesenchymal stem cell (MSC) therapy, Descartes-30, in patients with moderate-to-severe acute respiratory distress syndrome (ARDS), including that caused by COVID-19. Based upon the company's research and analysis, this program is understood to be the first RNA-engineered cell therapy to enter clinical development for ARDS and COVID-19. It is also the first cell therapy to specifically degrade NETs, webs of extracellular DNA and histones that entrap inflammatory cells, block alveoli and vessels, and drive the pathogenesis of ARDS and COVID-19.

"Patients with ARDS, especially those with COVID-19 ARDS, generate copious amounts of NETs that physically obstruct alveoli and vessels, which leads to respiratory distress, immune-mediated thrombosis and a vicious cycle of inflammation," said Bruce Levy, MD, Chief of Pulmonary and Critical Care Medicine at Brigham and Women's Hospital and Parker B. Francis Professor at Harvard Medical School, and a clinical investigator in the Descartes-30 trial. "We would therefore expect that degrading NETs would improve oxygenation as well as resolve thrombi and quell inflammation in these patients. If successful, Descartes-30 would be a highly differentiated game-changer within our limited toolkit in managing this exceedingly difficult condition."

Descartes-30 is an off-the-shelf (allogeneic) MSC product engineered with Cartesian's RNA ArmorySM cell therapy platform. By expressing a unique combination of DNases that work synergistically, Descartes-30 can eliminate large, macroscopic amounts of NETs within minutes. MSCs are inherently immunomodulatory and naturally travel to the lungs, where they are expected to provide continuous, local delivery of DNases to NET-laden lung tissue.

"We engineered Descartes-30 without genomic modification, and therefore the production of DNases is expected to be time-limited to match the acute nature of ARDS," said Metin Kurtoglu, MD, PhD, Chief Medical Officer at Cartesian. "Given thatDescartes-30will produce DNases locally and transiently, we anticipate that it will have a favorable benefit-to-risk profile. We also anticipate that these properties will enable Descartes-30 to treat a wide array of NET-related autoimmune and cardiovascular diseases."

About the Phase 1/2a Clinical Trial

The "Phase 1/2a Study of Descartes-30 in Acute Respiratory Distress Syndrome" (NCT04524962) is enrolling patients with ARDS at multiple critical care units in the United States. Patients with ARDS due to COVID-19 are given enrollment priority. This first-in-human study aims to determine the safety and preliminary efficacy of Descartes-30 in patients with moderate to severe ARDS. The study, which is estimated to begin treatment in September, aims to enroll approximately 20 patients prior to initiation of a larger study. For more information visit http://www.cartesiantherapeutics.com/Descartes-30-ARDS.

About ARDS and NETs

ARDS is a severe inflammatory lung disease with a mortality of over 40%. Inflammation leads to injury of lung tissue and leakage of blood and plasma into air spaces, resulting in low oxygen levels and often requiring mechanical ventilation. Inflammation in the lung may lead to inflammation elsewhere, causing shock and injury or dysfunction in the kidneys, heart, and muscles. Some causes of ARDS include COVID-19, severe pneumonia (including influenza), sepsis, trauma, and smoke inhalation.

NETs are inflammatory webs of DNA and proteins produced by neutrophils. NETs are commonly found in ARDS and are thought to exacerbate the disease by physically occluding air spaces and vessels, leading to reduced oxygenation and increased risk of immune thrombi. NETs are implicated in a variety of conditions beyond ARDS, including autoimmune and cardiovascular diseases.

About the RNA ArmorySM

The RNA ArmorySM is Cartesian's proprietary RNA-based cell engineering platform that activates and arms cells with carefully selected, mRNA-based therapeutics. Unmodified donor cells enter the RNA ArmorySMin the millions; a battle-ready cell army leaves the RNA ArmorySMin the tens of billions. Each cell is equipped with a combination of therapeutics rationally chosen to have a synergistic effect on the disease. In the body, the cells deliver a precision-targeted treatment regimen directly to the site of disease. The cells express therapeutics with a defined half-life, enhancing their safety profile and making repeat dosing and outpatient administration possible. The platform is agnostic to cell type: we choose the best cell for the job, whether autologous or off-the shelf. For more information visithttps://www.cartesiantherapeutics.com/rna-armory/.

About Cartesian Therapeutics

Founded in 2016,Cartesianis a fully integrated, clinical-stage biopharmaceutical company developing potent yet safer cell and gene therapies designed to benefit the broadest range of patients with cancer, autoimmune and respiratory diseases. Cartesianhas three products in clinical development under four open investigational new drug application (INDs) with the U.S. Food & Drug Administration (FDA). All investigational therapies are manufactured at Cartesian's wholly owned, state-of-the-art cGMP manufacturing facility in Gaithersburg, MD.Cartesian's commanding IP position benefits in part from a broad, exclusive patent license from the National Cancer Institute. For more information visithttps://www.cartesiantherapeutics.com/clinical-trials/.

SOURCE Cartesian Therapeutics

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Cartesian Therapeutics Initiates Clinical Trial of First RNA-Engineered Cell Therapy for Acute Respiratory Distress Syndrome and COVID-19 - PRNewswire