For those who keep up with Personalized Stem Cells in the news, you already know that we developed and secured FDA approval for a COVID-19 stem cell clinical trial in 2020. We went on to license this trial to Sorrento Therapeutics. The first trial was conducted at UCSF Fresno and had a strong safety and preliminary efficacy profile, which helped secure additional clinical trial approvals.
Shortly after the completion of the first clinical trial in the United States, Sorrento received clearance from the Brazilian Health Regulatory Agency (Anvisa) for a Phase 2 pivotal, multi-center, randomized, controlled study to evaluate the safety and efficacy of allogeneic mesenchymal stem cell therapy for the treatment of acute respiratory distress syndrome (ARDS) as a result of COVID-19 infection. Enrollment for the Phase 2 study was announced in September 2021.
The latest news also comes out of Brazil. Recently, Sorrento announced that Anvisa authorized a Phase 2 stem cell clinical trial for patients suffering with persistent pulmonary compromise as a result of COVID-19 (aka “long-haul COVID”). This will be a multi-center, randomized, placebo-controlled study in which Sorrento expects to enroll 60 patients. More information can be found here.
We are incredibly proud to see our hard work to develop and secure approval for the initial COVID-19 trial come to fruition in the form of multiple clinical trials. Sorrento has also worked very hard to secure rapid approvals for these additional clinical trials and we look forward to seeing positive results.