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 ...
Note: If you need assistance with your subscription or would like to discuss a corporate subscription for more than 10 employees please contact us or use the chat (bottom right).