Personalized Stem Cells, Inc (PSC), an adipose-derived stem cell company, announces the Brazilian Health Regulatory Agency (Anvisa) authorized a Phase 2 stem cell clinical trial for patients suffering with persistent pulmonary compromise as a result of COVID-19 (aka “long-haul COVID”). PSC has licensed this technology to Sorrento Therapeutics (Nasdaq: SRNE, “Sorrento”). According to the Centers for Disease Control and Prevention (CDC), long-haul COVID is a term used to describe a wide range of new, returning, or ongoing health problems that people can experience four or more weeks after first being infected with COVID-19.
The clinical trial, which is being conducted by Sorrento, is a multi-center, randomized, placebo-controlled Phase 2a study to evaluate the safety and efficacy of adipose-derived allogeneic (donor-derived) stem cells for patients experiencing respiratory issues recovering from a COVID-19 infection at least three months prior to enrollment. Sorrento expects to enroll 60 patients in the study and will use improvement in the 6-minute walk distance test as the primary outcome measure.
The new study is in addition to an ongoing Phase 2 COVID-19 stem cell clinical trial that is also being conducted in Brazil by Sorrento. Both trials are the result of a successful Phase 1b trial conducted in California at UCSF Fresno. In the initial Phase 1b study, ten patients that were hospitalized and required oxygen supplementation due to COVID-19, were all discharged from the hospital shortly after completing treatment with stem cells.
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 inflammatory diseases, including osteoarthritis and traumatic brain injury, granted 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 received an upfront payment and will be due royalties upon commercialization. PSC founder and CEO, Dr. Bob Harman, stated, “We are incredibly proud to see our hard work to develop and secure approval for the initial COVID-19 trial come to fruition in the form of multiple clinical trials. Sorrento has also worked very hard to secure rapid approvals for these additional clinical trials and we look forward to seeing positive results.”
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.