The Cure Alliance has teamed with University of Miami Health System and Jackson Health System in Miami, Florida, have been granted immediate FDA authorization for a 24-patient clinical trial to test the safety and exploratory efficacy of umbilical cord-derived mesenchymal stem cells (UC-MSCs) to block the life-threatening lung inflammation that accompanies severe cases of COVID-19. This cell therapy is administered intravenously. Led by Dr. Camillo Ricordi, the investigators are grateful to the FDA’s Center for Biologics Evaluations and Research, Office of Tissues and Advanced Therapies for performing four rounds of reviews in a record time of one week.
No Time to Waste
And the FDA could not afford to do anything other than move with record speed: “patients who die from COVID-19 have a median time of just 10 days between first symptoms and death. During severe cases, oxygen levels in the bloodstream drop and the inability to breath pushes patients towards their end very quickly; any intervention that might prevent that trajectory would be highly desirable,” reports Dr. Ricordi.
The Research Site
The trial will be conducted at the University of Miami Health System and Jackson Health System in Miami, Florida.
The Study Background
The study commenced as a result of a collaborative, international, academic initiative sponsored by the Cure Alliance, a non-profit group of scientists and innovators dedicated to sharing knowledge and accelerating cures for all diseases. The Cure Alliance has pivoted all resources to fighting the virus due to the pandemic.
The Cure Alliance has shared the clinical trial protocol with other academic institutions throughout the world who want to test similar treatment strategies in the fast and most efficient way possible. The Cure Alliance has allocated its funding to this clinical trial in the hopes of expanding the manufacturing of UC-MSC products. If this study outcome is safe and effective, the Cure Alliance will continue to direct any contribution received for this initiative to support future manufacturing and distribution of these cellular therapies.
For this study, Dr. Ricordi has enlisted additional experts from all over the world. These team members have extensive experience in infectious diseases, pulmonary medicine and critical care, while others bring expertise in cell-based product development and their use in clinical trials.
Who is the Cure Alliance?
With primary offices in Miami and Rome, the Cure Alliance is a 501(C)(3) non-profit group of top global scientists, researchers, medical doctors and innovators plus those who support their efforts to end suffering by developing cures for chronic, debilitating and fatal diseases. They have pivoted all of their efforts to concentrate on COVID-19.
Previous Stem Cell Approvals at University of Miami
The FDA has previously authorized the testing of UC-MSC cell products in patients with Type 1 diabetes and Alzheimer’s disease for select clinical trials.
Stem Cell Therapy Studies Growing around U.S.
TrialSite News recently reported on a range of stem cell therapy study approvals by the FDA. A race is on to save lives from COVID-19 and in severe cases including cytokine storm, little time remains. Hence, the FDA is opening up and offering approval to sponsors to commence stem cell-based research.
Dr. Camillo Ricordi, principal investigator, Stacy Joy Goodman Professor of Surgery and Director of the Diabetes Research Institute (DRI) and Cell Transplant Center at University of Miami Miller School of Medicine