As we all adjust to the “new normal,” many of us have had to shift our priorities. Our routines have changed, and many have experienced profound impacts on our personal lives. For some, our jobs have changed. And for all, our lives have changed. Here at Personalized Stem Cells, our staff has adjusted well. We have been able to maintain all of our employees and our parent company, VetStem Biopharma, has actually hired multiple new employees. We like to think of it as our little contribution to a troubled economy.
Clinical Trial Woes
But that is not to say that we have not had our own share of challenges since the COVID-19 outbreak was declared a global pandemic in March. One obstacle we had to overcome was the fact that we were in the middle of our first FDA approved clinical trial when everything shut down. As doctor’s offices adjusted their priorities and elective procedures were put on hold, new patient enrollment in our clinical trial suffered.
And we were not the only ones. According to analysis by Medidata, a healthcare data services company, clinical trial enrollment was down an astonishing 70% in April 2020 compared to October 2019. Seventy percent! That is huge! But not all that surprising considering the state of affairs in April. As COVID numbers began to level out, Medidata reported a 30% decrease in enrollment as of the end of June 2020.
Getting Back on Track
By the end of May, we were happy to announce that our clinical trial enrollment was able to resume. Doctor’s offices modified their practices to meet FDA recommendations to slow the transmission of the virus and in-person appointments and procedures resumed. As enrollment picked up, we knew we were close to reaching our projected goal of clinical trial participants.
And we were right! In early August we were proud to announce that enrollment of our first FDA approved clinical trial was complete. 38 patients were enrolled to have one arthritic knee treated with their own stem cells. With enrollment complete, we have begun to shift our focus to data collection. Our goal is to have data submitted to the FDA by the end of the year.
A Milestone Worth Celebrating
Enrollment completion is a major milestone in the world of clinical trials. According to analysis by Tufts Center for the Study of Drug Development, recruiting enough participants can be a major challenge when conducting clinical trials. Additionally, low enrollment rate has been identified as one of the biggest reasons clinical trials are terminated. At best, low or slow enrollment can prolong the duration of the trial and delay analysis of results. At worst, a clinical trial will never get off the ground.
Not only did we overcome these statistics, we did it in the middle of a global pandemic. And just one year after we received FDA approval, an accomplishment in and of itself. We are very proud to work with a dedicated group of investors and clinical trial investigators and their staff, without whom none of this would have been possible. Stay tuned for more clinical trial news!