Personalized Stem Cells (PSC) enrolled the first of up to 125 patients in its FDA-approved clinical trial for stem cell treatment of knee osteoarthritis. Trial sites are located throughout the U.S., with more to come in 4Q19 and early 2020. Future trials are planned for other orthopedic applications, including hips and shoulders.
PSC is working within FDA's regulations to provide stem cell therapies that follow FDA's guidelines, assuring consistent manufacturing, quality-tested cells and clinical trial/manufacturing oversite for safety and efficacy.
Michael Dale, Chief Executive Officer, said, “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.”
Mr. Dale and PSC co-founder Robert J. Harman are biotechnology entrepreneurs who have led multiple biotech companies. PSC's Medical Director, Christopher Rogers, M.D., specializes in non-surgical treatment of spine and joint conditions and has developed novel approaches to treat tendon injuries, osteoarthritis and disc degeneration that provide viable alternatives to surgery.
Source: Personalized Stem Cells, Inc.