Personalized Stem Cells, Inc (PSC), an adipose-derived stem cell company, announces the Brazilian Health Regulatory Agency (Anvisa) authorized a Phase 2 COVID-19 stem cell clinical trial. This approval comes shortly after the completion of a Phase 1b trial conducted in California at UCSF Fresno. The trial, which is being conducted by Sorrento Therapeutics (Nasdaq: SRNE, “Sorrento”), will be 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.
In the initial Phase 1b 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. Sorrento expects to enroll 100 patients in the new study, with 33 placebo and 67 treated patients. The stem cell treatments, which were developed by PSC and then licensed to Sorrento, will be administered every other day for a total of three infusions.
FDA approval for the Phase 1b clinical trial conducted in the United States was secured by PSC in July 2020. PSC, which primarily focuses on orthopedics, went on to grant global rights to its adipose derived allogeneic mesenchymal stem cell (MSC) program, including the COVID-19 therapy candidate, to Sorrento Therapeutics in October 2020. PSC contracted Performance Cell Manufacturing to manufacture stem cells for use in the clinical trial.
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, 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.