Personalized Stem Cells (PSC) treated the first patients in an FDA-approved clinical trial for stem cell treatment of knee osteoarthritis (OA). The company received FDA approval for the trial earlier this year.
The multi-site trial will treat up to 125 patients throughout the U.S. Additional clinical trial sites will be added in the coming months.
This is the first of several planned trials that will allow qualified PSC-enrolled physicians to provide FDA compliant, quality cell therapy to patients suffering from OA. A series of FDA approved trials will expand to other applications, like trauma, in the future.
PSC works within FDA's 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.