Performance Cell Manufacturing was contracted to manufacture stem cells for an FDA-approved stem cell clinical trial to treat COVID-19 induced acute respiratory distress syndrome (ARDS). The clinical trial, which was developed by Personalized Stem Cells, Inc. (PSC) and licensed to Sorrento Therapeutics (Nasdaq: SRNE, “Sorrento”), recently reached its target enrollment of ten patients.
The first positive results from the clinical trial came in January, followed by updated results in March. The latest announcement from Sorrento confirmed that target enrollment was reached, and all ten clinical trial participants were discharged from the hospital.
According to Sorrento, all ten patients were in the hospital with 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. The clinical trial called for the patients to receive one intravenous infusion of stem cells every other day for a total of three infusions however the final patient was discharged after only two injections with oxygen saturations in the high 90s.
The objective of this non-randomized, Phase 1b study 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. There were no infusion-related adverse events reported in any of the patients. Data from the clinical trial 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.
The stem cell platform and FDA approval for the clinical trial were secured by Personalized Stem Cells shortly after COVID-19 was declared a global pandemic. Personalized Stem Cells granted global rights to its adipose-derived allogeneic mesenchymal stem cell (MSC) program, including the COVID-19 therapy candidate, to Sorrento in October 2020.