Mount Sinai Health System will be conducting a study using remestemcel-L (Ryoncil), an innovative allogeneic stem cell therapy in patients with coronavirus disease 2019 (COVID-19). Mount Sinai will play a central role in a clinical trial for patients with severe acute respiratory distress syndrome, which affects individuals with severe cases of COVID-19.
What is Remestemcel-L?
Consisting of mesenchymal stem cells, this therapy has been previously assessing for other indications such as in a Phase III study involving children who had graft-versus-host disease (GVHD)—these can happen after bone marrow transplants. Of relevance for the recent COVID-19 pandemic, the inflammation involved with GVHD can result from a cytokine storm—the same phenomenon that can occur with COVID-19 patients when developing acute respiratory distress syndrome (ARDS).
TrialSite News recently discussed the FDA’s greenlight of Mesoblast’s Investigational New Drug (IND) application for Remestemcel-L. The sponsor could now commence with clinical trials addressing acute respiratory distress syndrome (ARDS) caused by SARS-CoV-2 infection with intravenous infusions of its allogeneic mesenchymal stem cell (MSC). The sponsor decided to move forward based on evidence that the experimental regenerative therapy has had positive impact on ARDS in experimental settings. The experimental regenerative therapy was previously tested in patients who have had a bone marrow transplant, who can experience an overactive immune response similar to that observed in severe cases of COVID-19.
Mount Sinai: A Leading Clinical Investigational Site
By late March, Mount Sinai became involved with the study administering remestemcel-L to patients under the FDA’s compassionate use program. According to a report from CancerNetwork, the provider administered the procedure to 10 patients with moderate to severe COVID-19 cases involving ARDS, most of whom were on ventilators. The Mount Sinai investigators saw encouraging results.
This stem cell therapy-based clinical trial has been set up to evaluate the safety of remestemcel-L for 240 patients with COVID-19 related ARDS in both the United Stated and Canada. As reported by CancerNetwork, Mount Sinai shall serve as the clinical and data coordinating center. The trial is conducted via a public-private partnership with the Cardiothoracic Surgical Trials Network.
Keren Osman, MD, medical director of the Cellular Therapy Services in the Bone Marrow and Stem Cell Transplantation Program at the Tisch Cancer Institute at Mount Sinai and associate professor of Hematology and Medical Oncology at the Icahn School of Medicine, noted, “We are encouraged by what we have seen so far and look forward to participating in the randomized controlled trial starting soon that would better indicate whether this is an effective therapy for patients in severe respiratory distress from COVID-19.”
Keren Osman, MD, medical director of the Cellular Therapy Services in the Bone Marrow and Stem Cell Transplantation Program at the Tisch Cancer Institute at Mount Sinai and associate professor of Hematology and Medical Oncology at the Icahn School of Medicine