Personalized Stem Cells, Inc (“PSC”), a human adipose-derived stem cell company, has successfully enrolled the first patient in an FDA approved clinical trial for stem cell treatment of knee osteoarthritis. The successful enrollment comes only a little more than one year after formation of the company as a subsidiary of VetStem Biopharma.
PSC CEO, Michael Dale, stated, “We are proud that as we celebrate the first anniversary of the formation of the company, we are also celebrating the successful enrollment of the first patient in our first FDA approved clinical trial. This is a remarkable feat considering what is required to develop and validate stem cell processing procedures, clinical protocols, and the FDA application process.”
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 Q4 2019 and early 2020.
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 will use stem cells to treat osteoarthritis in the knee. In just two months, PSC has recruited, trained, and qualified clinical trial sites sufficient to treat up to 125 patients in this first clinical trial.
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 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 Robert Harman, DVM, MPVM and Michael Dale, both of whom also co-founded VetStem Biopharma and are both experienced serial entrepreneurs.