Today, we are facing a crisis that is unlike anything most of us have seen in our lifetimes. COVID-19 has brought health systems across the world to the fringe and forcefully closed schools, restaurants, events, and many other places around the world where we gather. The pandemic has killed countless lives and caused havoc in the lives of millions of workers. The ramifications of the pandemic are social and economic and will likely be felt for some time to come. [Read more…]
Stem Cell News
BioInformant's coverage of stem cell news includes iPS cells, mesenchymal stem cells, hematopoietic stem cells, neural stem cells and more.
As the first and only market research firm to specialize in stem cell news, BioInformant research has been cited by the Wall Street Journal, Xconomy, AABB, and Vogue Magazine.
Serving Fortune 500 leaders that include GE Healthcare, Pfizer, and Goldman Sachs, BioInformant is your global leader in stem cell industry news.
Citius to Pursue IND for Use of Its Induced MSCs in COVID-19 Induced ARDS
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Citius receives FDA Response on Pre-IND application for its induced mesenchymal stem cells (iMSCs) to treat ARDS induced by COVID-19
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FDA provides specific guidelines to study iPSC-derived MSCs, preparing Citius to submit an IND application for its iMSC therapy
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The Citius iMSC is an allogeneic MSC product manufactured by expanding material from a master cell bank
Celltex Therapeutics Receives Another FDA Approval: Phase II Clinical Trial Using MSCs a Prophylactic Against COVID-19
June 26, 2020, HOUSTON — Celltex, a Houston, Texas-based biotechnology company, announced that it has received approval from the U.S. Food and Drug Administration (FDA) to proceed with the Company’s Investigational New Drug application (IND 22055) to investigate the Prophylactic Efficacy of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) Against Coronavirus Disease 2019 (COVID-19). [Read more…]
Orca Bio Raises $192M Series D to Develop High Precision Allogenic Cell Therapies
Company aims to safely and effectively regenerate a healthy blood and immune system for patients with hematological malignancies, genetic diseases and autoimmune disorders
High precision cell therapies manufactured by Orca Bio have the potential to replace conventional bone marrow transplants and expand the eligible patient population
Cynata to Launch World’s First Phase 3 Trial with an iPSC-Derived Cell Therapeutic
With an anticipated enrollment of 440 patients, it will be the world’s largest trial ever completed with an iPSC-derived cell therapeutic.
It’s official. Australian stem cell company Cynata Therapeutics is preparing to test its iPSC-derived cell therapeutic, CYP 004, in a Phase 3 clinical trial enrolling up to 440 patients. Led by the University of Sydney and funded by the Australian Government National Health and Medical Research Council (NHMRC), the historic trial will assess whether Cynata’s cell therapeutic, CYP-004, has the capacity to improve patient outcomes in osteoarthritis (OA).
CYP-004 is an allogeneic, iPSC-derived mesenchymal stem cell (MSC) product derived using Cynata’s proprietary Cymerus™ technology. The clinical trial is set to achieve two world-firsts:
- It will be the world’s first clinical trial involving an iPSC-derived cell therapeutic product to enter Phase 3.
- It will be the largest trial ever completed with an iPSC-derived cell therapeutic, with an anticipated enrollment of 440 patients.
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