MINNEAPOLIS — The University of Minnesota is opening a new FDA-approved clinical trial for the treatment of COVID-19.
The trial aims to prove the effectiveness of mesenchymal stem cells (MSC).
The treatment's goal is to halt "the intense inflammatory response of the body," which is the immune system's response to the coronavirus.
The response is referred to as the “cytokine storm.”
“The inflammation seen in patients with severe COVID-19 can be devastating,” said David Ingbar, MD, a critical care and pulmonary physician at the M Health Fairview. “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 study is open at M Health Fairview UMMC and Bethesda Hospital, which was previously converted into the state's first dedicated COVID-19 care facility, researchers said.
“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.”
MSCs have been used successfully to treat inflammatory diseases and single doses are being piloted in other countries for the treatment of COVID-19.