Last week, founder and CEO of Personalized Stem Cells, Inc. (PSC) and VetStem, Inc., Dr. Bob Harman, delivered a talk at the American Academy of Orthopaedic Surgeons second annual Biologics Symposium. The symposium, which took place in Washington, DC, centered on the use of real-world evidence in biologics. Experts in science, medicine, and industry, along with regulatory agencies convened to examine what we currently know about real-world evidence as it pertains to musculoskeletal medicine.
Dr. Harman was asked to speak on his use of real-world evidence to help guide the development of efficacious and safe orthobiologic therapies now and in the future. Pulling from nearly two decades’ worth of experience in veterinary regenerative medicine, Dr. Harman discussed the use of his company’s veterinary stem cell data in the development of human stem cell clinical trials as well as the value and challenges of creating a biologics data registry.
VetStem began providing autologous (patient-derived) veterinary stem cell treatments to veterinarians for their patients back in 2004. Utilizing the data from nearly 15,000 patient treatments, Dr. Harman formed a human stem cell company, Personalized Stem Cells (PSC), in 2018. The company quickly secured approval for their first IND and in 2019, PSC launched their first FDA approved clinical trial for the treatment of knee osteoarthritis, which produced favorable results.
PSC went on to successfully secure FDA approval for a clinical trial to study the treatment of COVID-19 with allogeneic (donor-derived) intravenous stem cells in July 2020. The trial was later out licensed to a biotechnology company. The initial Phase 1b trial was conducted in California at UCSF Fresno. In the study, ten patients that were hospitalized and required oxygen supplementation, were all discharged from the hospital shortly after completing treatment with stem cells. These promising results helped secure approval for additional Phase 2 studies in Brazil including a randomized, placebo-controlled trial and a trial for long-haul COVID.