CEO and founder of Personalized Stem Cells, Inc (PSC), Dr. Robert Harman, recently presented clinical trial results at the annual International Federation for Adipose Therapeutics and Science (IFATS) meeting in Ft. Lauderdale, FL. PSC, an adipose derived stem cell company, completed their first clinical trial in early 2021 and the results were very promising. The FDA approved phase 1/2a clinical trial studied the safety and preliminary efficacy of autologous, adipose derived stem cells for the treatment of knee osteoarthritis.
As announced earlier this year, the clinical trial results were very promising. Safety was the primary objective and there were no serious adverse events reported. The preliminary efficacy results were also positive. Efficacy was measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS) and showed that 79.3% of the patients improved above the “minimal important change” (MIC) with an average improvement over baseline of 2.2 times the MIC. The KOOS measures pain, other symptoms, daily function, sports, and knee related quality of life outcome sub-scales.
Results from PSC’s knee osteoarthritis trial were also presented at The Orthobiologic Institute (TOBI) conference in early October 2021. PSC Medical Director, Dr. Christopher Rogers, delivered an informative talk discussing the safety and efficacy results of the phase 1/2a clinical trial.
PSC plans to launch a phase 2 placebo-controlled knee osteoarthritis trial in the coming months. Additionally, PSC plans to pursue FDA approval for a stem cell clinical trial to treat traumatic brain injury (concussion). Stem cell therapy may provide answers and tools to address the chronic debilitation experienced by TBI victims. Recent studies have found that stem cells have demonstrated the ability to regenerate damaged nerve tissues which may lead to an improvement in disabilities and thereby quality of life.