Mount Sinai Health System in New York is the first in the United States to use allogeneic stem cell therapy to treat COVID-19.
Mount Sinai began using stem cells for COVID-19 treatment in late March 2020 in the framework of the compassionate program of the Food and Drug Administration (FDA) to allow patients in life-threatening conditions to receive experimental treatment. Stem cell therapy was performed in 10 patients with moderate and severe acute respiratory distress syndrome, most of them were undergoing assisted lungs ventilation. Doctors noted the encouraging results of cell therapy.
This medical center also plays a key role in the development of a clinical trial protocol for the evaluation of the effectiveness of cell therapy of acute respiratory distress syndrome, other respiratory disorders and COVID-19.
The stem cell preparation remestemcel-L, which is used in patients with coronavirus pneumonia, has previously been used in the treatment of immunological complications after bone marrow transplantation. The drug contains mesenchymal stem cells capable of suppressing an excessive inflammatory response (“cytokine storm”), which underlies the development of both severe coronavirus pneumonia and transplant-versus-host syndrome. Courtesy of this ability of mesenchymal stem cells, for a long time they have been used in the treatment of a number of autoimmune diseases (multiple sclerosis, Crohn’s disease, ulcerative colitis, systemic lupus erythematosus, etc.).
“Because of the results we see we are looking forward to a randomized controlled clinical trial that will better determine whether cell therapy is effective in treating COVID-19 respiratory distress syndrome,” says Dr. Keren Osman, associate professor of hematology and medical oncology in Mount Sinai.
In New York, stem cell treatment is planned to be conducted in 240 patients with acute coronavirus-induced respiratory distress syndrome.
In Ukraine, the Institute for Cell Therapy has developed a clinical trial protocol for the treatment of coronavirus COVID-19 pneumonia (pathogen SARS-CoV-2) using cryopreserved allogeneic multipotent placental and umbilical cord stem cells.
Actually, about 300 units of cryopreserved mesenchymal stem cells isolated from the human placenta and umbilical cord, are ready for use at the Cryobank of the Institute of Cell Therapy. Cell preparations are manufactured in accordance with international standards. Each drug contains more than 70 million cells, which is sufficient to treat an adult patient with COVID-19-induced pneumonia.