Personalized Stem Cells, Inc (“PSC”), a human adipose-derived stem cell company, has completed training and site qualification for clinical trial sites and physician investigators. The clinical trial sites are now in the process of recruitment and screening of potential clinical trial participants.
Clinical trial sites are currently located in San Diego and Los Angeles California, Portland Oregon, and Chicago Illinois. 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 for use of a person’s own adipose-derived stem cells to treat their osteoarthritis in clinical trials. The 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.
“We are fortunate to have thought leaders and experienced regenerative medicine physicians and support staff to launch our first clinical trial. We look forward to expanding the physician network as additional clinical trials are approved in the near future. The high demand for FDA approved stem cell therapy has created a terrific opportunity for visionary and highly skilled physicians to work with PSC and within FDA regulation.” says Mr. Dale.
PSC has enrolled a limited number of clinical sites around the U.S. to provide treatment of knee osteoarthritis using stem cells. The physicians in this first clinical trial are among the most experienced stem cell physicians in the country. Contact PSC for clinical trial information, clinical trial site locations, or investment information.