Experimental stem cell therapy trial for COVID-19 initiated
Researchers announce the first patient has been dosed in a trial testing remestemcel-L, a stem cell therapy, in severe COVID-19 patients on ventilators.
Testing of an experimental COVID-19 stem cell therapy has begun in the US. The therapy has been developed to treat hospitalised COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS) who are on ventilators. A total of 300 are expected to be recruited into the randomised, placebo-controlled trial.
The trial, in which patients will either receive the drug remestemcel-L or a placebo in addition to the recommended standard of care, is being conducted by University of Maryland School of Medicine (UMSOM) researchers at the University of Maryland Medical Center (UMMC) and additional sites across the US. The first patient was treated at UMMC.
The therapy was developed by Mesoblast Limited, who are also funding the study to determine whether the drug reduces the risk of death within 30 days after the onset of treatment and whether it reduces the number of days from a ventilator to recovery.
“This stem cell therapy is a potential new therapy in our treatment arsenal to battle COVID-19,” said Dr Sunjay Kaushal, Professor of Surgery at UMSOM and Chief of the University of Maryland Congenital Heart Disease Outreach Program. “There is an urgent need to find new life-saving therapies for our sickest COVID-19 patients who are suffering from ARDS and require ventilators. We are eager to see whether remestemcel-L can reduce mortality in these patients.”
Remestemcel-L is an experimental stem cell therapy developed for various inflammatory conditions. It is thought to reduce the production of pro-inflammatory cytokines to lessen inflammation. This could be of therapeutic benefit in severe COVID-19 patients, because symptoms such as ARDS are believed to be the result of cytokine storms, an exaggerated immune response that creates potentially fatally high levels of inflammation.
The trial will include other hospitals in the University of Maryland Medical System that have COVID-19 patients who meet the criteria. “As we extend the reach of this study to other UMMS hospitals, we affirm our commitment as an academic health system to explore all avenues to improve the health of the people we serve,” said Dr Mohan Suntha, President and Chief Executive Officer of the University of Maryland Medical System. “Our hope is that research efforts like this and others we are pursuing in the midst of a novel coronavirus pandemic will help save lives.”
The researchers expect enrolment to be complete within four months. The trial may be stopped early if interim analysis reveals remestemcel-L is working well or not working at all. Potential adverse effects of the treatment include rejection of the cells and other immune reactions.