Three COVID-19 patients at Baptist Hospital of Miami – all critically ill with acute respiratory distress syndrome (ARDS) – are the first in the U.S. to successfully be treated with umbilical cord mesenchymal regenerative cell therapy.
In a clinical trial being conducted under an emergency approval from the Food and Drug Administration (FDA), Baptist Health physicians Guenther Koehne, M.D., Ph.D., and Javier Pérez-Fernández, M.D., safely administered the new treatment to patients through intravenous infusions of experimental umbilical cord lining-derived cellular therapy (ULSC).
(Watch Now: Ruthie Ramirez, 32, one of the first COVID-19 patients in the U.S. successfully treated with mesenchymal stem cell therapy, is greeted by her children and coworkers after spending three weeks in Baptist Hospital.)
Regenerative Cell Therapys was produced by RESTEM, a leading-edge biotechnology company dedicated to the discovery and development of cell-based therapy. RESTEM’s cells are grown from umbilical cord tissue by a proprietary process and reduce inflammation, thereby allowing tissue regeneration and healing to occur.
The patients who received the treatment were on ventilation support and showed reduction of their oxygen requirement from 100 percent to less than 50 percent within days of the infusion. This was accompanied by a significant reduction in levels of various key circulating inflammatory markers, meaning the harmful inflammation crippling the lungs of all three patients was not only arrested but reversed.
“The remarkable ability for these cells to mitigate inflammatory processes holds great promise for COVID-19 patients as well as for people with many other illnesses,” said Dr. Koehne, deputy director and chief of blood & marrow transplant at Miami Cancer Institute, part of Baptist Health, and Principal Investigator for the study, which is currently undergoing review at the FDA. “These patients have improved their lung status much more quickly than patients treated with other experimental therapies.”
All three patients were critically ill and suffered from significant co-morbidities, or underlying conditions, according to Dr. Koehne, who is also professor and chairperson of the Department of Translational Medicine at the Herbert Wertheim College of Medicine (HWCOM) at Florida International University (FIU). Specialists at HWCOM spearheaded this collaborative effort between academia, Baptist Health and RESTEM.
Dr. Pérez-Fernández, pulmonologist and director of critical care at Baptist Hospital, is extremely impressed with the outcomes they’ve seen so far. “Our preliminary results show that regenerative cell therapy with these cells could be a game-changer in COVID-19.”