For those who follow our blog, you are probably aware that Personalized Stem Cells (PSC) developed and received FDA approval for a COVID-19 stem cell clinical trial in 2020. We then went on to out-license this clinical trial, along with our allogeneic stem cell platform, to Sorrento Therapeutics. By licensing out this trial/platform, we were able to return our focus to our primary mission: autologous stem cell therapy for orthopedic conditions such as knee osteoarthritis. For those who are not familiar with the story, below you will find some history as well as the most recent update regarding the current Phase 2 COVID-19 stem cell clinical trial being conducted in Brazil.
Stem Cells for COVID-19
In the early pandemic days, PSC went to work to manufacture doses and secure FDA approval for a COVID-19 stem cell clinical trial. We received FDA approval to conduct the clinical trial in July of 2020 and went on to out license the program in October of 2020. Equipped with nearly 20 years of cell therapy data and experience from our veterinary company, VetStem, we believe stem cells may be the key to overcoming complications from COVID-19 infection.
As discussed in a peer-reviewed scientific article published by PSC and collaborating scientists on the rationale behind using stem cells to treat COVID-19, mesenchymal stem cells (MSCs) have demonstrated the capacity to inhibit lung damage, reduce inflammation, dampen immune responses and aid with alveolar fluid clearance. Additionally, MSCs produce molecules that are antimicrobial and reduce pain. Recently, the application of MSCs in the context of ongoing COVID-19 disease and other viral respiratory illnesses has demonstrated reduced patient mortality and, in some cases, improved long-term pulmonary function.
Phase 1b Clinical Trial Results
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 Clinical Trial
Recently, we announced that the first patient was officially enrolled in the Brazilian Phase 2 clinical trial. 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. Now that enrollment has begun, we expect additional updates in the coming months regarding treatment and enrollment milestones. Stay tuned!