Personalized Stem Cells, Inc (PSC), a human adipose-derived stem cell company, announces that the first patients have received stem cell therapy for the treatment of COVID-19 as part of an FDA approved clinical trial. The ongoing clinical trial and stem cell platform, which PSC developed and then licensed to Sorrento Therapeutics (Nasdaq: SRNE, “Sorrento”), is being conducted at UCSF Fresno. 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 acute respiratory distress syndrome (ARDS) resulting from infection with COVID-19.
Patients enrolled in the clinical trial will receive three intravenous infusions of stem cells every other day. The treatments, termed COVI-MSC™ by Sorrento, have been administered to four patients thus far. According to the most recent announcement by Sorrento, all four patients have completed treatment and have been discharged from the hospital ICU. The treatments were tolerated well and the patients improved rapidly. There were no infusion related adverse events reported in any of the patients.
Shortly after COVID-19 was declared a global pandemic, PSC contracted Performance Cell Manufacturing, a division of VetStem Biopharma, to manufacture stem cells for the clinical trial. To jumpstart the process and speed stem cell manufacturing, a San Diego-based biotechnology company, Calidi Biotherapeutics, collaborated with PSC to provide critical cell lines.
At the request of the White House Coronavirus Task Force, PSC submitted an Investigational New Drug (IND) application to the FDA in April 2020 and received approval 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.