Personalized Stem Cells, Inc (PSC), a human adipose-derived stem cell company, has announced that enrollment is officially complete for their FDA approved stem cell clinical trial for treatment of knee osteoarthritis. 38 patients are participating in the clinical trial to have one knee treated with their own stem cells.
To participate in the clinical trial, patients must be suffering from knee osteoarthritis and meet enrollment criteria. Clinical trial participants undergo a liposuction procedure to collect a sample of adipose (fat) tissue. This tissue is processed at PSC’s FDA inspected laboratory where technicians isolate and extract each patient’s stem and regenerative cells. Each patient receives one injection of their own stem cells into the affected knee.
This enrollment milestone is an important step forward in the completion of the clinical trial. PSC CEO, Dr. Robert Harman, stated, “We are fortunate to have a fully enrolled trial which will allow us to move forward in the FDA approval process. While stem cells have previously been used successfully in the treatment of osteoarthritis, our goal is to produce high quality data and ultimately receive FDA approval so that arthritic patients have access to PSC’s quality tested stem cell treatments.” Dr. Harman noted that the enrollment completion milestone comes just one year after receiving FDA approval to begin the clinical trial, an accomplishment in and of itself.
With enrollment complete, the company will begin to focus on data collection and compilation. PSC aims to compile and submit clinical study data to the FDA by the end of 2020 after which a Phase II blinded, placebo-controlled study will be launched. In addition to the knee trial, PSC recently received FDA approval to launch a clinical trial for the treatment of COVID-19 patients with stem cells. The company also plans to pursue FDA approval of stem cells for the treatment of back pain and traumatic brain injury (concussion), as well as arthritis affecting other joints.
PSC was founded in 2018 by Robert Harman, DVM, MPVM and Michael Dale, both of whom also co-founded VetStem Biopharma and are both experienced serial entrepreneurs. With a goal to advance and legitimize stem cell therapy for people, PSC works within strict FDA regulations to provide high-quality stem cell processing services, as well as excellent technical, clinical, and regulatory support to physicians, clinical investigators, and patients.