A collaborative analysis of coronavirus studies indicates that cell-based therapy is safe for COVID-19 patients with acute respiratory distress syndrome (ARDS) and may have beneficial clinical effects, according to a study published by a University of Miami Miller School of Medicine researcher.
“Administering mesenchymal stem cells (MSCs) to COVID-19 patients with life-threatening respiratory problems appears be a safe form of therapy,” said Joshua M. Hare, M.D., Louis Lemberg Professor of Medicine and founding director of the Interdisciplinary Stem Cell Institute (ISCI) at the Miller School of Medicine. “Large-scale multicenter clinical trials will be the next step in determining whether MSCs improve patient outcomes. We are excited that UM will be participating in a major national effort to identify whether cell therapy should be pursued for this condition, and what the ideal source of cells should be.”
Dr. Hare was co-author of the collaborative study, “Cell-Based Therapy to Reduce Mortality from COVID-19: Systematic Review and Meta-Analysis of Human Studies on Acute Respiratory Distress Syndrome,” published June 5 in the journal Stem Cells Translational Medicine. The analysis included co-authors from the Mayo Clinic, Duke University, Case Western Reserve University, and Emory University.
For this analysis, the authors reviewed three decades of respiratory distress studies through March 31, and found nine involving the administration of MSCs to 200 coronavirus patients with Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS), and COVID-19. All three coronaviruses can result in fatal acute respiratory distress syndrome.
“Safety is the most important concern for all new investigational therapies, especially in patients at high risk for death from the condition being treated,” said Dr. Hare. “Our analysis found no related serious adverse events to study participants – only mild reactions that resolved spontaneously. Combined mortality showed a favorable trend but did not reach statistical significance.”
Dr. Hare said COVID-19 has been associated with an intensive care unit admission rate of approximately 5 percent of proven infections. Current treatment for patients with acute lung injuries is supportive, but the mortality rate ranges from 22 to 88 percent for ICU patients, he added.
On April 5, the U.S. Food and Drug Administration gave authorization for ISCI to administer MSC investigational product for seriously ill COVID-19 patients as an “expanded access compassionate use.” Since then, ISCI has offered access to MSCs that may reduce the severe inflammation in the lungs caused by the immune system’s reaction to the coronavirus infection.
“The potential benefits of MSC therapy for patients with COVID-19 acute respiratory distress syndrome support the rapid commencement of clinical trials, as well as the compassionate use of MSCs,” said Dr. Hare. “We also need to study MSCs derived from different sources to see if that might make a difference in patient outcomes.”
Researchers from several institutions involved in the meta-analysis are submitting a collaborative proposal to the FDA for a multicenter trial on the efficacy of MSC therapy, said Dr. Hare. “New treatment modalities are clearly needed to save lives by addressing the underlying processes that affect the lungs in COVID-19 patients with acute respiratory distress syndrome.”
ISCI will serve as one of the manufacturing sites for this major national effort. ISCI also is one of five Production Assistance for Cellular Therapies (PACT) centers for the National Heart, Lung, and Blood Institute, and has supported other national cell-based therapy trials funded by the National Institutes of Health.
“Now that we are a mature manufacturing facility, we are extremely well positioned to adjust and accommodate changing needs such as COVID-19 and scale up production when needed to produce hundreds of batches of MSCs,” said Aisha Khan, executive director of the ISCI Laboratory Operations.
“ISCI is committed to be the leader in the field of regenerative medicine by continuously pushing the limits and applying new ideas to expand this field for the good of humanity. We are constantly evaluating our processes for further improvements and learning new techniques and skills to develop more potent cells by effectively comparing different types of MSCs to treat COVID-19.”