In our most recent blog, we shared an update regarding the COVID-19 stem cell clinical trial that Personalized Stem Cells developed and secured FDA approval for. The trial, which we licensed to Sorrento Therapeutics, is studying the effects of allogeneic (donor derived) stem cell therapy for acute respiratory distress syndrome (ARDS) as a result of COVID-19 infection. In our last blog, we shared that nine COVID-19 patients had received treatment and were discharged from the hospital within days of completing treatment with stem cells. But the clinical trial recently reached a new milestone!
Clinical Trial Enrollment Milestone and Results
We recently announced that the COVID-19 stem cell clinical trial reached the target enrollment of ten patients. The latest announcement comes just over three months after the initial treatment in the clinical trial. According to our licensee, Sorrento Therapeutics, all ten patients had low oxygenation and required oxygen supplementation. Within three days of their last stem cell infusion, all ten patients were discharged from the hospital and sent home.
Clinical Trial Safety Data
As a Phase 1b non-randomized study, the objective is to evaluate the safety and preliminary efficacy of adipose-derived stem cell therapy for the treatment of ARDS resulting from infection with COVID-19. The clinical trial called for the patients to receive one intravenous infusion of stem cells every other day for a total of three infusions. Nine patients received all three infusions while the tenth patient was discharged after the second stem cell infusion with oxygen saturations in the high 90s. According to Sorrento, there have been no infusion related adverse events.
These preliminary results are very promising and will be used to support a planned placebo-controlled pivotal study which is expected to take place across multiple sites in the United States and Brazil. We are honored to be a part of such a monumental project.