Personalized Stem Cells, Inc (PSC), a human adipose-derived stem cell company, announces that all clinical trial participants have received treatment in the FDA approved stem cell clinical trial for treatment of knee osteoarthritis. This treatment milestone comes just two months after the company announced the trial was fully enrolled. Clinical trial participants received one injection of their own stem cells into the affected
knee.
PSC investigators will continue to collect data until all patient’s have completed their final evaluation 84 days after their treatment. The data will then be compiled and analyzed prior to FDA submission. Stem cell therapies/products are regulated by the FDA and must undergo a thorough approval process to assess the potential benefits versus the potential risks for the intended population.
PSC President, Michael Dale, stated, “This treatment milestone comes just eleven months after the first clinical trial participant was treated. We are optimistic that the data will demonstrate the relative safety of autologous adipose-derived stem cell therapy for knee osteoarthritis.” PSC aims to compile and submit clinical study data to the FDA in the first quarter of 2021, after which a Phase 2 blinded, placebo-controlled study will be launched. While Phase 1 studies focus on safety, the emphasis of Phase 2 studies is on effectiveness.
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. This Phase 1 study will include 20 hospitalized patients in California. 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.