In February, Personalized Stem Cells, Inc (PSC), a human adipose-derived stem cell company, shared news that the first patients were treated in an FDA approved stem cell clinical trial to treat COVID-19 induced acute respiratory distress syndrome (ARDS). At the time of the initial announcement, four ICU patients had completed treatment and were discharged from the hospital. The ongoing clinical trial was developed by PSC and licensed to Sorrento Therapeutics (Nasdaq: SRNE, “Sorrento”).
The latest announcement from Sorrento includes updated results in a total of nine patients treated with allogeneic adipose-derived stem cells. All nine patients were in the hospital ICU with poor oxygenation and all nine patients were discharged from the hospital within days after completing the stem cell treatments. In addition, there have been no infusion related adverse events reported in any of the patients.
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 ARDS resulting from infection with COVID-19. The stem cells used for treatment, termed COVI-MSC™ by Sorrento, were manufactured by Performance Cell Manufacturing, a contract development and manufacturing organization contracted by PSC. Patients enrolled in the clinical trial receive three COVI-MSC™ intravenous infusions, one treatment every other day.
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. The ongoing clinical trial is being conducted at UCSF Fresno.
PSC CEO, Dr. Bob Harman, stated, “We are extremely proud to hear more positive news regarding the ongoing COVID-19 stem cell clinical trial. At the onset of the global pandemic, our team felt called to action to utilize our 15+ years of experience with stem cell manufacturing in an effort to make a difference. With each positive announcement, it becomes clearer that we achieved that goal. We look forward to future positive announcements from our licensee, Sorrento Therapeutics.”
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.