Personalized Stem Cells, Inc (“PSC”), a human adipose-derived stem cell company, has successfully enrolled the first patients in an FDA approved clinical trial for stem cell treatment of knee osteoarthritis. The first treatment came shortly after the one-year anniversary of the formation of the company as a subsidiary of VetStem Biopharma.
In July of 2019, PSC received FDA approval for a New Drug (IND) application to conduct clinical trials for use of a person’s own adipose-derived stem cells to treat their osteoarthritis. This first clinical trial uses stem cells to treat osteoarthritis in the knee.
PSC has recruited, trained, and qualified clinical trial sites sufficient to treat up to 125 patients in this first clinical trial. Clinical trial sites are currently located in San Diego and Los Angeles California, Portland Oregon, Chicago Illinois, and New Jersey. Additional clinical trial sites are anticipated in coming months.
PSC CEO, Michael Dale, stated, “We are pleased with the response from patients who suffer from knee arthritis and with the diligence and enthusiasm of the participating clinics around the country. We expect to rapidly increase enrollment in this first clinical trial as we prepare for additional clinical trials using stem cells for orthopedic injuries.”
This is the first of several planned clinical trials which will enable qualified PSC-enrolled physicians to provide FDA compliant, quality cell therapy to patients suffering from osteoarthritis. PSC plans to conduct a series of FDA approved clinical trials starting with uses in orthopedics and expanding to other medical conditions such as trauma in the future.
PSC is working within the FDA cell therapy regulations to provide stem cell therapy for patients that follows the rules FDA has created in order to assure consistent manufacturing, quality tested cells and clinical trial and manufacturing oversite for safety and efficacy.
PSC was founded by Michael Dale, CEO, and Robert Harman, DVM, MPVM, Chief Scientific Officer, both of whom also co-founded VetStem Biopharma and are both experienced serial entrepreneurs.