We have more exciting news regarding our FDA approved stem cell clinical trial for knee osteoarthritis! In January, Personalized Stem Cells announced that data collection for the clinical trial was complete. (You can read that blog here.) Recently, we announced that the final study report has been submitted to the FDA and the preliminary safety and efficacy results are very promising!
Knee Osteoarthritis Clinical Trial Safety
Clinical trial milestones are always significant. Being that this is our first clinical trial however, each new milestone brings us a great sense of pride. This phase 1/2a clinical trial was to study the use of stem cell therapy for single knee osteoarthritis and was primarily focused on safety. As part of the FDA approval process, you must first confirm that your treatment is safe. In our case, we wanted to prove that treatment with autologous (patient derived) adipose-derived stem cells would not cause serious harm to the recipients. And we are happy to report that no serious adverse events were reported in any of the clinical trial participants!
What About Efficacy?
It is, of course, crucial to know that an experimental therapy is safe, but what about efficacy? Current and potential future stem cell recipients want to know whether or not the treatment actually works. While this clinical trial primarily focused on safety, the preliminary efficacy results are also very promising! According to the data, 79.3% of the clinical trial participants improved after receiving stem cell therapy. Improvement was based on the Knee Injury and Osteoarthritis Outcome Score (KOOS) which measures pain, other symptoms, daily function, sports, and knee related quality of life outcome sub-scales.
Next Step: Phase 2 Clinical Trial
Now that FDA submission is complete and the data is promising, we plan to move into a phase 2 clinical trial for knee osteoarthritis. A phase 2 trial primarily focuses on efficacy and will be larger than the phase 1 trial. We plan to launch that clinical trial this year.