Personalized Stem Cells, Inc (PSC), an adipose-derived stem cell company, announces that the data collection process is complete for their Phase I FDA approved stem cell clinical trial for the treatment of knee osteoarthritis. In early October 2020, the company announced that the last clinical trial participant received treatment with their own stem cells. The final data collection point came in late December 2020.
Now that data collection is complete, PSC will begin the process of compiling and analyzing the data prior to FDA submission. Stem cell therapies/products are regulated by the FDA and must undergo a thorough approval process to assess safety and efficacy for the intended population.
PSC founder and CEO, Dr. Bob Harman, stated, “Despite the challenges resulting from a global pandemic, we are proud to have reached this milestone in our first FDA approved clinical trial. We are optimistic that the data obtained from the Phase 1 study will demonstrate the relative safety of autologous stem cell therapy for knee osteoarthritis, and we look forward to presenting this data to the FDA.” PSC aims to compile and submit clinical study data to the FDA by the end of the quarter, after which a Phase 2 blinded, placebo-controlled study will be next. While Phase 1 studies focus on safety, the emphasis of Phase 2 studies is on effectiveness.
In addition to a Phase 2 knee trial, PSC plans to pursue FDA approval for a stem cell clinical trial to treat traumatic brain injury (concussion) in 2021. 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.