RESTEM, a leading-edge biotechnology company, and Baptist Health South Florida, today announced three COVID-19 patients with acute respiratory distress syndrome (ARDS) are the first to successfully be treated in the U.S. with umbilical cord mesenchymal stem cells 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 RESTEM’s experimental umbilical cord lining-derived stem cells (ULSC).
The patients who received this treatment showed a reduction of their oxygen requirement from 100% to less than 50% within days of the infusion, accompanied by a significant reduction in levels of various key circulating inflammatory markers.
“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 Guenther Koehne, MD, Ph.D., deputy director, and chief of blood & marrow transplant at Miami Cancer Institute, part of Baptist Health.
“These patients have improved their lung status much more quickly than patients treated with other experimental therapies,” added Dr. Koehne, who is also a professor and chairperson of the Department of Translational Medicine at the Herbert Wertheim College of Medicine (HWCOM) at Florida International University (FIU).
“Our preliminary results show that therapy with these cells could be a game-changer in COVID-19,” stated Dr. Javier Perez-Fernandez, pulmonologist, and director of critical care at Baptist Hospital of Miami.
RESTEM’s cells are grown from umbilical cord tissue by a proprietary process and reduce inflammation, thereby allowing tissue regeneration and healing to occur.
Rafael Gonzalez, Ph.D., Senior Vice-president of Research and Development at RESTEM, stated “we are extremely excited with these preliminary results. The SUCCESS (Systemic Umbilical Cord Cells to Erase Syndrome Severity) Trial will identify COVID-19 ARDS patients that may best benefit from ULSC and will develop randomized placebo-controlled evidence regarding the ability of these cells to heal patients with this terrible disease.” Dr. Koehne is the Principal Investigator of the SUCCESS Trial undergoing review at the FDA entitled “Phase 1/2a Study of Umbilical Cord Lining Stem Cells (ULSC) in Patients with ARDS due to COVID-19.”
The RESTEM ULSC have also been cleared by the FDA for testing their healing properties in the autoimmune conditions of Polymyositis and Dermatomyositis. Patients will also be able to participate in this clinical trial both at the Miami Cancer Institute and at Sanford Health in Sioux Falls, South Dakota.