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.
Aspire Health Science Receives IND Approval to Test ACT-20 Cellular Therapy Against COVID-19 Pneumonia
Aspire Health Science Announces U.S. FDA approval of IND application regarding testing proprietary ACT-20 Cellular Therapy against COVID-19 Pneumonia and a partnering opportunity for Biotech Companies and Investors.
FibroGenesis Reports COVID-19 Breakthrough Using Fibroblast Cell Therapy (Pre-Clinical Trial Phase)
PneumoBlast™ Reduces Pathology and Lung Fluid Accumulation in Model of COVID-19
HOUSTON, May 21, 2020 — FibroGenesis announced significant efficacy of its PneumoBlast™ product in an animal model of lung inflammation which resembles COVID-19. Mice immune systems were stimulated to enter hyper-activation mode, which causes symptoms similar to COVID-19. Once COVID-19 simulation was achieved, administration of PneumoBlast™ resulted in significant reduction in lung fluid accumulation. Additionally, reduction was observed from infiltration of inflammatory cells, as well as suppression of chemical mediators such as interleukin-6 (IL-6), which are associated with poor survival in COVID-19 patients. [Read more…]
Organicell Reports Positive Results from Compassionate Use of Organicell Flow in Severely Ill COVID-19 Patients
Miami, FL (May 27, 2020) – Organicell Regenerative Medicine, Inc. (OTCBB:BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, announced today a health update for two critically ill COVID-19 patients who were treated at Landmark Hospital in Athens, GA with the Company’s Organicell Flow product. These patients were treated under the two recently approved Emergency Compassionate Use Investigational New Drug applications (eINDs) by the U.S. Food and Drug Administration (FDA). [Read more…]
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