Subject: Cell Therapy Industry News - July 2023

Breaking news about stem cells, cord blood, exosomes, CAR-T, and beyond.

StemCyte to Supply Raw Materials for Immune Cell Therapies Derived from Umbilical Cord Blood


BALDWIN PARK, CA — As international demand for starting substances for use in cell therapy emerges, California-based regenerative therapeutics company StemCyte announced it has signed a cooperation agreement with a leading US cell therapy company that is developing allogeneic genetically modified CAR-NK cells using umbilical cord blood. StemCyte has agreed to supply the necessary cellular raw materials for allogeneic cell therapy product development worldwide.

Pivotal Trends Impacting the Cord Blood and Tissue Industry in 2023


The cord blood and tissue industry came into existence in the early 1990’s with the formation of several cord blood banks in the U.S. and worldwide. It has been 40 years since it was first proposed that stem and progenitor cells were present in human cord blood. Today, six pivotal themes are impacting the global cord blood industry, including: 1. Diversification of Services, 2. Pairing with Genetic Testing Services, 3. Pairing with Fertility and Assisted Reproduction Services, 4. Accelerating Industry Consolidation, 5. Becoming Integrated Therapeutic Companies, and 6. Progress with Cord Blood Expansion Technologies. Read on to learn more about this rapidly evolving global market.

Cell Genesis Launches CEXCI Cord Protein Banking: A Revolutionary Advancement in Stem Cell Science


July 7, 2023, Singapore, Singapore — Cell Genesis has announced the launch of CEXCI Cord Protein Banking, a groundbreaking initiative that marks a new era in the field of stem cell research and personalized medicine. This innovative approach harnesses the power of umbilical cord stem cells protein to unlock a world of possibilities for improved health outcomes.

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Cryoport

Advanced Extracellular Vesicle Analytics for Your Advanced Therapy


Fully characterizing and defining an EV-based therapy requires access to sophisticated and expensive equipment along with dedicated expertise. RoosterBio has invested in advanced analytical instrumentation and qualified a set of standard assays to help you understand potency, purity, identity, size, quantity, content, and more. Let RoosterBio become your analytical core facility, and we will provide you with the critical measurements required to define your EVs.  

Direct Biologics Announces Significant Survival Benefit with ExoFlo™ in its Phase 2 Randomized Clinical Trial


AUSTIN, Texas– Direct Biologics, LLC, a late-stage biotechnology company leveraging its regenerative medicine platform using extracellular vesicles (EVs) secreted from bone marrow-derived mesenchymal stem cells (BM-MSCs) to address multiple disease indications, announces favorable safety data and significant efficacy results from its Phase 2 clinical trial (NCT04493242) of ExoFlo™ in hospitalized adult COVID-19 patients with moderate-to-severe acute respiratory distress syndrome (ARDS).

Exosomes as a therapeutic paradigm is a new and potentially revolutionary technology


The 5th Exosome Based Therapeutic Development Summit has become a must-attend meeting for those looking to meet and network with drug developers, pioneering academics and solution providers to accelerate exosome therapeutics, and harness their unique targeting capabilities to deliver therapeutic cargo. This forum is your opportunity to Unlock Native and Engineered Exosomes with Improved Targeting, Optimize Analytics & Achieve Large-Scale Manufacturing for Effective Translation into the Clinic and Towards Commercialization. 


With 30+ expert speakers and 7+ hours of networking this is an opportunity you do not want to miss!  See the full agenda here to find out more.

Axol Bioscience and StrataStem to Deliver iPSC-Derived ‘Clinical Trial in a Dish’ for Alzheimer’s Disease


CAMBRIDGE, England & EDINBURGH, Scotland — Axol Bioscience has signed an exclusive agreement with StrataStem to access and commercialize its extensive collection of Alzheimer’s Disease (AD) patient samples. Harnessing its stem cell expertise, Axol will reprogram these patient samples into iPSCs that can then be differentiated into a wide range of brain cells, including neurons and neuroinflammatory cells. Grown in vitro, these cells can provide patient specific human brain models from a large cohort of AD patients – to create a ‘clinical trial in a dish’.

StemBioSys Launches CELLvo™, Human iPSC-Derived Atrial Cardiomyocytes for Cardiotoxicity Screening


SAN ANTONIO, June 13, 2023 — StemBioSys, Inc. (StemBioSys) announced the launch of CELLvo™ Atrial Cardiomyocyte, a “chamber specific” human induced pluripotent stem cell derived cardiomyocyte (hiPSC-CM) designed to function identically to human atrial cardiomyocytes. StemBioSys developed CELLvo™ Atrial Cardiomyocyte to empower pharmaceutical companies and academics with a more precise, efficient and cost-effective platform for screening new drug products in vitro for cardiotoxicity compared to animal models and other in-vitro methods currently in use.

IPS HEART Advances Development of ISX9-CPC, a Drug Candidate that Reprograms iPSCs into New, Functional Heart Muscle


HOUSTON–IPS HEART, a privately held cell therapy company advancing its stem cell platform to develop new skeletal muscle and cardiac muscle generation treatments for Duchenne muscular dystrophy (a rare disease) and heart failure, today announced that the U.S. Food and Drug Administration (FDA) awarded a third Rare Pediatric Drug Designation (RPDD) for its product candidate, ISX9-CPC, for treatment of cardiomyopathy associated with Danon disease. ISX9-CPC stem cell therapeutic candidate is designed to create new functional human heart muscle along with reducing cardiac fibrosis.

RoosterBio EV Analytical Services

Neobiosis Announces FDA Approval of IND for Use of ViXome™ in COVID-19 ‘Post Covid Syndrome’


GAINESVILLE, Fla., – Neobiosis is a leading research and manufacturing biotech company focused on pioneering the development of novel therapeutics from perinatal tissues as a new class of medicines. Neobiosis announced that the U.S. FDA has approved the IND application for ViXome™, its drug for the treatment of ‘Post COVID Syndrome. ViXome, an acellular product derived from amniotic fluid, contains a heterogeneous population of growth factors, cytokines, chemokines, microRNAs and exosomes, which in pre-clinical testing has demonstrated potent immunomodulatory and pro-reparative effects.

Saint-Gobain Life Sciences and denovoMATRIX announce investment and expansion of service agreement


DRESDEN, Germany, 20 June, 2023 – denovoMATRIX GmbH, an innovator in cell and gene therapy manufacturing, and Saint-Gobain Life Sciences have expanded their Master Service Agreement with a special focus on products related to the Stem Cell therapy market. At the same time, Saint-Gobain Life Sciences’ investment arm NOVA announces its strategic investment into denovoMATRIX.

How Topical Application of Stem Cell Serum May Reverse COVID-Induced Hair Loss


Covid-19 is said to cause long-term side effects in up to 67% of patients, and these health consequences can include chronic fatigue, loss of taste and smell and brain fog. Increasingly common too is Covid-related hair loss. Known as telogen effluvium, this phenomenon manifests as clumps of hair falling out after brushing or washing your hair.

CellCelector Flex

Exosomes: Company Spotlights from “A” to “Z”


Exosomes are small vesicles ranging from 30-100nm in size that are found in nearly all eukaryotic fluids and facilitate a range of important cellular functions. They transfer DNA, RNA, and proteins to other cells, thereby altering the function of the targeted cells. In recent years, exosomes have gained attention as a strategy for accessing the therapeutic effects of cells without the risks and difficulties of administering the cells to patients.

Exosomes as a Burgeoning New Frontier in Cell-Free Therapeutics


Despite decades of investigation, stem cell therapies are still facing challenges around their commercialization. Some researchers now believe that the regenerative benefits of stem cell therapy are mediated, at least in part, by the exosomes these cells secrete. These exosomes can readily be harvested from stem cells cultured within a bioreactor, purified, and infused into a patient’s body. From this perspective, exosomes are simpler, safer, and more easily transported than whole cells.

Trailhead Biosystems Puts iPSCs on a New Path


Biotech founder and CEO Jan Jensen has never been one for following the beaten track. As a young scientist studying the formation of insulin-producing pancreatic cells, Jensen questioned the prevailing view that these cells descended from neuroectoderm. His pancreatic embryonic tissue studies told him otherwise: insulin-producing pancreatic cells originate from within the pancreas itself. Jensen’s hypothesis, now the accepted view, and his further studies made him the first developmental biologist at Novo Nordisk, at a time when the world’s largest insulin producer had little interest in cell-based therapy. Now, 20 years later, Novo Nordisk is at the forefront of cell-based Type I Diabetes research.

Induced Pluripotent Stem Cell (iPSC) Industry Trends Dominating in 2023


iPSCs are laboratory-made pluripotent stem cells that are produced using non-controversial adult cells. They are derived from somatic cells through reprogramming and turning on the expression of specific pluripotency genes. This reprogramming can be achieved using different techniques with varying efficiencies. Today, iPSCs are being explored for applications related to basic and applied research, drug screening, toxicological studies, disease modeling, cell therapy, personalized medicine, cultured meat production, and beyond.

The Pipeline for iPSC-Derived Cell Therapeutics in 2023


Today, there are approximately 50 cell therapy companies worldwide that are developing induced pluripotent stem cell (iPSC) derived cell therapeutics for use in human patients. In general, the targets for iPSC-derived therapies include any diseases or disorders for which there are no other viable treatments and where there is a need to repair or replace dysfunctional tissue. This article presents a list of all known companies and organizations that are forging the path toward iPSC-derived cell therapeutics.

Biolife Solutions

Global Induced Pluripotent Stem Cell (iPSC) Industry Report - Market Size, Trends, and Forecasts, 2023


In addition to those who are developing iPSC-derived cell therapeutics, there are an ever-growing number of  competitors who are commercializing iPSC products for use across a diverse range of applications. These applications include drug development and discovery, disease modeling, toxicology testing, and personalized medicine, as well as tissue engineering, 3D bioprinting, and clean meat production. This report reveals all major iPSC market competitors worldwide and presents a market size breakdown for iPSCs by Application, Technology, Cell Type, and Geography (North America, Europe, Asia/Pacific, and RoW). Importantly, it also presents future market projections through 2030.

Global Cord Blood & Tissue Banking Industry Report – Market Size, Segmentation, & Forecasts, 2023


This global strategic report includes a detailed market size determination, with breakdown by geography, indication, and type of bank, as well as future projections for each segment through 2030. It reveals the number of cord blood units stored in inventory by the largest cord blood banks worldwide, as well as the total storage count for both public and private units in storage worldwide. It also presents the number of cord blood units (CBUs) released by registries across the world for HSCT. Importantly, it reveals the identities of companies offering cord blood storage, cord blood processing technologies, cord blood expansion technologies, and cord blood therapeutics on a global basis. 

To access other market insights about CAR-T cell therapy, MSCs, iPSCs, cord blood, and beyond, explore the BioInformant Shop.

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