For those of you who follow our blog, you probably know that we launched a human stem cell company in 2018. Click here for a refresher. Since then, Personalized Stem Cells (PSC) has received FDA approval for two investigational new drug (IND) applications.

Knee Osteoarthritis Clinical Trial

The first FDA approved clinical trial was for the treatment of knee osteoarthritis. Data was submitted to the FDA for this trial earlier this year and the 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 in the coming months.

COVID-19 Clinical Trial

The second IND was for a COVID-19 clinical trial. In the early days of the pandemic, PSC went to work to manufacture stem cells and secure FDA approval for a clinical trial to study the effects of stem cell therapy to treat COVID-19. We announced the news back in July 2020 here on the VetStem blog. But the good news didn’t stop there!

In October 2020, PSC entered into a licensing agreement with Sorrento Therapeutics and granted them global rights to their allogeneic (donor-derived) stem cell program, including the COVID-19 clinical trial. This was a lucrative move for the company and allowed PSC experts to return focus to autologous (patient-derived) stem cell treatments.

Phase 1b COVID-19 Clinical Trial Results

Results from the first COVID-19 clinical trial were very promising. The initial Phase 1b clinical trial was conducted in California at UCSF Fresno. In the initial study, ten patients that were hospitalized and required oxygen supplementation, were all discharged from the hospital shortly after completing treatment with stem cells. These promising results helped secure approval for the Phase 2 study in Brazil earlier this year.

Brazilian Phase 2 COVID-19 Clinical Trial

The latest news from Sorrento is that the first patient was recently enrolled in the Brazilian COVID-19 study. This trial, which, like the Phase 1b trial is being conducted by Sorrento Therapeutics, is a randomized, placebo-controlled study designed to evaluate the safety and efficacy of three allogeneic (donor-derived) mesenchymal stem cell infusions administered on varying schedules in 100 patients suffering from acute respiratory distress syndrome (ARDS) as a result of COVID-19 infection. The hope is that the results of this trial will mirror the results of the initial clinical trial and that this treatment modality will eventually become more accessible.

We couldn’t be prouder of the work we do here at VetStem and also at Personalized Stem Cells. Without the 15+ years of VetStem data from veterinary stem cell treatments, PSC would likely not be here. And to know that we contributed to potentially saving lives affected by COVID-19 is really something spectacular. We also want to thank all of YOU, our pet owners and veterinary clients, for trusting VetStem to handle your pets’ and patients’ stem cells. We couldn’t do what we do without you!