Personalized Stem Cells, Inc (PSC), an adipose-derived stem cell company, announces the first patient has been enrolled in a Brazilian Phase 2 COVID-19 stem cell clinical trial. The trial, which is being conducted by Sorrento Therapeutics (Nasdaq: SRNE, “Sorrento”), 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 initial Phase 1b 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. Additionally, Sorrento plans to begin enrollment for two more Phase 2 COVID-19 stem cell studies including a parallel Phase 2 placebo-controlled safety study to be conducted across multiple sites in the United States and a pulmonary long-hauler Phase 2 safety and efficacy study across multiple sites in Brazil.
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.
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.