Just three months after the initial treatments, Personalized Stem Cells, Inc (PSC), a human adipose-derived stem cell company, announces enrollment is complete for COVID-19 FDA approved stem cell clinical trial licensed to Sorrento Therapeutics (Nasdaq: SRNE, “Sorrento”). The clinical trial and stem cell platform, which PSC developed and then licensed to 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.
The clinical trial called for the patients to receive one intravenous infusion of stem cells every other day for a total of three infusions. Ten patients were enrolled in the clinical trial and 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. 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.
FDA approval for the clinical trial 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.