As most of you know, VetStem spun out a human stem cell company several years ago called Personalized Stem Cells. We like to provide occasional updates for those who may be interested, and it has been a few months since our last update. Since then, there have been some exciting developments regarding clinical trials.

Knee Osteoarthritis Clinical Trial Update

The first FDA investigational new drug approval to research stem cell use secured by Personalized Stem Cells (PSC) was for single knee osteoarthritis. The clinical trial was launched shortly before the COVID-19 pandemic. Despite the challenges presented by the pandemic, PSC was able to safely and successfully complete clinical trial enrollment and treatments by the end of 2020. 39 patients were enrolled in the clinical trial.

Since our last update, Personalized Stem Cells hit another milestone. In January, they announced that all data for the clinical trial was collected and preparations for FDA submission were taking place. And in March, PSC officially announced that all clinical trial data was submitted to the FDA. The preliminary results look very promising. PSC reported that over 79% of patients improved and there were no serious adverse events reported. With the first clinical trial under their belts, PSC plans to launch a larger, placebo-controlled trial later this year.

COVID-19 Clinical Trial Update

Since our latest PSC update blog in March, a lot has happened with the COVID-19 stem cell clinical trial. For reference, PSC developed the investigational new drug and secured FDA approval for the clinical trial shortly after the pandemic began. They went on to license the clinical trial to Sorrento Therapeutics in October 2020.

The most recent news came earlier this month when PSC announced that enrollment was complete for the COVID-19 clinical trial. The results look very promising. Ten patients received allogeneic stem cell therapy for treatment of COVID-19 induced acute respiratory distress. All ten patients were hospitalized prior to treatment and required oxygenation supplementation. And all ten patients were discharged from the hospital shortly after their final stem cell injection. Data from this clinical trial will be used to support a placebo-controlled study which is expected to take place in multiple sites in the United States as well as in Brazil.

Planned Future Clinical Trials

In addition to the phase 2 knee osteoarthritis study, PSC plans to pursue FDA approval for a traumatic brain injury (concussion) study. Stem cell therapy may provide answers and tools to address the chronic debilitation experienced by TBI victims. Recent studies by others have found that stem cells have demonstrated the ability to regenerate damaged nerve tissues which may lead to an improvement in disabilities and thereby the quality of life.

To keep up with Personalized Stem Cells, follow their blog and Facebook page.