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!

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.

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