University of Minnesota 1st in U.S. to open clinical trial to treat inflammation related to COVID-19

The University of Minnesota announced Thursday the first patient with severe COVID-19 and lung failure has been treated on a new clinical trial that will test the effect of three doses of mesenchymal stem cells on the body's inflammatory response to COVID-19. 

The treatment is designed for the sickest COVID-19 patients and attempts to halt the inflammatory response of the body, known as cytokine storm. The cytokine storm is caused by the body’s immune response to COVID-19 and, if unchecked, can cause extensive organ damage and lung failure.

“The inflammation seen in patients with severe COVID-19 can be devastating,” said Dr. David Ingbar, a critical care physician at M Health Fairview University of Minnesota Medical Center. “The cytokine storm can rapidly lead to shock, massive fluid buildup in the tissues and direct severe tissue injury, most often in the lungs.”

The U of M led and developed the study which is open at M Health Fairview University of Minnesota Medical Center and Bethesda Hospital--the state’s first dedicated COVID-19 care facility.

“The study will determine the effect of MSCs on stopping the cytokine storm,” said John E. Wagner, MD, cancer researcher and director of the Institute for Cell, Gene and Immunotherapy at the University of Minnesota. “In order to determine the real benefit of MSCs in these very ill patients, patients will be randomized to receive three doses of MSC 48 hours apart or a placebo solution.” 

Pilot studies with a single low dose of MSC in other countries, including China and Italy, have shown safety and possible beneficial effects in a small number of patients.