For COVID-19 patients in severe respiratory distress, the University of Miami Miller School of Medicine now offers access to mesenchymal stem cell (MSC) treatments that may help fight the characteristic inflammation that accompanies the viral infection.
On April 5, the U.S. Food and Drug Administration (FDA) approved MSC treatments for seriously ill COVID-19 patients as an “expanded access compassionate use.” Since then, UM has provided clinicians in Miami and Maryland with MSCs taken from bone marrow and cultured at the Interdisciplinary Stem Cell Institute (ISCI) manufacturing lab. Six COVID-19 patients with serious breathing difficulties have shown improvement after receiving MSC infusions along with other treatments. The sixth patient, who was on ECMO, was recently injected at Jackson Memorial Hospital.
“Early reports from China indicated that MSCs could be helpful in treating COVID-19 patients in severe respiratory distress,” said Jose Guillermo Castro, M.D., professor of infectious diseases at the Miller School and director of the antibiotic stewardship program at UHealth Tower. “We offer that form of therapy through ISCI and are cautiously optimistic that it can be helpful.”
Aisha Khan, executive director of laboratory operations at ISCI, said MSCs can help address an immune system over-response to a COVID-19 infection called a “cytokine storm,” referring to small proteins that produce inflammation, damaging the lungs and other organs. “Stem cells don’t make the virus disappear, but they help the body fight this disease,” said Khan. “By suppressing the cytokine storm, they can help a patient regain breathing ability.”
On April 7, Sixto Alejandro Arias, M.D., an interventional pulmonologist with UHealth – the University of Miami Health System, gave an initial infusion of MSCs to a patient in his 40s, who tested positive for COVID-19 in mid-March and was admitted to UHealth Tower with severe respiratory problems.
“Stem cells have been widely used to treat interstitial lung disease, and we felt this could be a safe and helpful therapy,” said Dr. Arias. “He received other forms of treatment as well; we don’t know how much the MSCs helped his condition. But we are very gratified to see him improve, and he is now out of intensive care.” That patient has since been discharged from UHealth Tower.
In early April, ISCI shipped MSCs to clinicians at the University of Maryland who were treating two patients with no other options. Both initial patients and two additional patients did well, and their levels of inflammation went down, according to Khan.
“We are so pleased to be able to offer this experimental therapy, working closely with our colleagues on the front lines taking care of these critically ill patients,” said Joshua M. Hare, M.D., Louis Lemberg Professor of Medicine and founding director of ISCI.
Khan said ISCI is making both bone marrow and umbilical cord-derived MSCs available for treating COVID-19 patients throughout South Florida. The FDA recently approved a clinical trial led by UM’s Diabetes Research Institute and Cell Transplant Center that will test the safety and effectiveness of umbilical cord-derived MSCs.
“Our staff members are working night and day to build our inventory, and we now have the ability to treat about 50 patients,” Khan said. “We plan to continue growing our inventory because the need for COVID-19 treatments is so great.”