2020 was a whirlwind of a year for most of us. Individuals, families, and businesses all over the world were affected by the global pandemic. Nobody expected the year’s crazy turn of events, and most of us found ourselves in uncharted territory when it came to managing our daily lives and our businesses. 2020 also happened to be the year that we conducted our first FDA approved clinical trial. It was not ideal timing, to say the least.
Lockdowns and Restrictions
When COVID-19 was declared a global pandemic, states all over the U.S. went on lockdown. This meant non-essential businesses were closed, schools converted to virtual learning, and doctor visits and procedures were limited to only those that were deemed necessary.
At the time, our FDA approved stem cell clinical trial for knee osteoarthritis was well underway. Several participants had already received treatment and were in the process of receiving follow up examinations. In addition, new patients were being screened and enrolled in the clinical trial. Needless to say, the appointments for screening, enrolling, and procedures were put on hold. Fortunately, the FDA did allow the follow-up visits for participants who had already been injected to be done remotely so that the important safety information would not be lost.
Getting Back to Business
In May of 2020, we were finally able to get the ball rolling again for new potential participants. Doctor’s began seeing and treating patients again, following FDA and CDC safety guidelines to slow the transmission of the virus. Fortunately, this meant that our clinical trial could continue moving forward as well.
Fast forward a couple of months and we announced that enrollment for the clinical trial was complete. Just a few short months after that, we announced that all the clinical trial participants had received treatment. This was a major milestone for us. Not only is this our first FDA approved clinical trial, but we managed to pull it off during truly unprecedented times.
Another Major Milestone
With clinical trial treatments complete, the next phase for the team at Personalized Stem Cells is data compilation and analysis. So, we were very excited to announce that we received the last batch of data at the end of December 2020! This means that we can focus our efforts on compiling and analyzing data for FDA submission.
Our goal is to have everything ready for FDA submission by then end of the first quarter this year. Assuming everything goes smoothly, we will then progress into a blinded, placebo-controlled Phase 2 clinical trial. While the Phase 1 study focuses on safety, the Phase 2 study will focus on effectiveness. We could not be more excited and proud of all the hard work that has been poured into this trial. We sincerely thank all of PSC’s investors, clinical trial investigators and teams, and clinical trial participants. And we look forward to conducting more clinical trials in the near future!