Personalized Stem Cells, Inc. (PSC), a privately held regenerative medicine company based in Poway, California, submitted a grant application to the California Institute of Regenerative Medicine (CIRM) for funds to treat COVID-19 patients in an FDA-approved clinical trial. According to the CIRM website, “CIRM funds promising stem cell research in California to accelerate stem cell treatments to patients with unmet medical needs.” CIRM personnel were instrumental in assisting with the budgeting, application, and review process.
PSC is preparing to launch an FDA-approved clinical trial to treat hospitalized COVID-19 patients with stem cells. Founder and CEO, Dr. Bob Harman, stated, “We immediately recognized the potential of stem cell therapy for treatment of COVID-19 patients based on the experience and intellectual property of our parent company.” In multiple recent studies, stem cell therapy has been shown to reduce patient mortality, and in some cases, improve long-term lung function.
PSC’s phase 1 clinical trial will be conducted in 20 hospitalized patients in California. PSC will provide stem cell treatments to clinical trial participants at no cost to the patient. If the CIRM application is approved, the funds would provide support for this first trial and allow PSC to focus on rapid expansion of treatment for additional patients in a phase 2 clinical trial, for approved expanded access, or for use under an Emergency Use Authorization by the Federal Government. Dr. Harman stated, “We produced stem cell doses sufficient to treat patients in the phase 1 clinical trial. Additional funding from CIRM will provide the resources that we need to further expand stem cell production for a phase 2 study.”
PSC’s medical director recently led an international group of COVID-19 researchers in the publication of a peer-reviewed paper discussing the medical rationale for stem cell therapy as a treatment option for COVID-19. This key publication, entitled “Rationale for the Clinical Use of Adipose-Derived Mesenchymal Stem Cells for COVID-19 Patients,” was published in the Journal of Translational Medicine and provides the basis for PSC’s FDA approved clinical trial as well support for the CIRM application. First author and PSC medical director, Dr. Christopher Rogers, stated, “I believe this is the most promising therapy being explored by medical scientists at this time. Stem cells may potentially reduce the most serious complications of coronavirus infection.”