Planned Clinical Trial of Allogeneic Stem Cell Therapy Remestemcel-L in Patients with COVID-19

Mount Sinai Health System announced that they will be using remestemcel-L (Ryoncil), an innovative allogeneic stem cell therapy, in patients with coronavirus disease 2019 (COVID-19).

Additionally, Mount Sinai indicated that they 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.

Remestemcel-L has previously been 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 began administering remestemcel-L to patients in late March under the FDA’s compassionate use program. The therapy was given to 10 patients with moderate to severe cases of COVID-19-related acute respiratory distress syndrome (ARDS), most of whom were on ventilators, and the doctors saw encouraging results. 

“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 Service 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 at Mount Sinai, said in a press release. 

The randomized clinical trial evaluating the therapeutic benefit and safety of remestemcel-L will be conducted at Mount Sinai, which will serve as the clinical and data coordinating center. The stem cell therapy will be evaluated in 240 patients with COVID-19-related ARDS in the US and Canada. Moreover, the trial will be conducted as a public-private partnership between the Cardiothoracic Surgical Trials Network.

“The coronavirus pandemic has caused exponential increases of people suffering with acute respiratory distress syndrome, requiring intubation and mechanical ventilation with many dying,” Annetine Gelijns, PhD, the Edmond A. Guggenheim Professor of Health Policy at the Icahn School of Medicine at Mount Sinai, said in a press release. “We have designed a clinical trial that will expeditiously determine whether the stem cell therapy will offer a life-saving therapy for a group of patients with a dismal prognosis.”

Remestemcel-L consists of mesenchymal stem cells. The therapy was previously assessed in a phase III trial in children who had graft-versus-host disease (GVHD), which can occur after bone marrow transplants. Further, the inflammation that occurs in GVHD is the result of a cytokine storm. A similar cytokine storm has been found to take place in patients with COVID-19 who develop acute respiratory distress syndrome.

“These stem cells have shown excellent response rates in severe graft-versus-host disease in children,” John Levine, MD, professor of Hematology, Medical Oncology, and Pediatrics at the Icahn School of Medicine at Mount Sinai, who is also the co-director of the Mount Sinai Acute GVHD International Consortium (MAGIC), said in a press release. “Mesenchymal stem cells have a natural property that dampens excessive immune responses.”

Some institutions have also begun testing anti-IL-6 agents, such as tocilizumab (Actemra), for the treatment of cytokine release syndrome in patients with COVID-19 who develop acute respiratory distress syndrome.

Reference:

Mount Sinai Leading the Way in Innovative Stem Cell Therapy for COVID-19 Patients [news release]. New York, NY. Published April 9, 2020. newswise.com/coronavirus/mount-sinai-leading-the-way-in-innovative-stem-cell-therapy-for-covid-19-patients/?article_id=729684&sc=dwhr&xy=10019792. Accessed April 15, 2020.