Mount Sinai Leading the Way in Innovative Stem Cell Therapy for Covid-19 Patients
Mount Sinai Health System starts a clinical trial to use an innovative allogeneic stem cell therapy in Covid-19 patients. Given it is the first of its kind, the patient outcomes could be important for various reasons.
Compassionate Use
Mount Sinai started the treatment, called remestemcel-L, in patients weeks ago under the Food and Drug Administration’s compassionate use program.
“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,” said 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 Medicine (Hematology and Medical Oncology) at the Icahn School of Medicine at Mount Sinai. Dr. Osman has directed the treatment on Mount Sinai patients with this innovative therapy.
Clinical Trial Leaders
Annetine Gelijns, PhD, Alan Moskowitz, MD, and Emilia Bagiella, PhD, are the clinical trial leaders at Mount Sinai. They have launched a randomized clinical trial to assess the efficacy on 240 patients with Covid-19.
The Cardiothoracic Surgical Trials Network and Mesoblast, the manufacturer of the stem cells, collaborate with Mount Sinai to proceed with this study.
“The coronavirus pandemic has caused exponential increases of people suffering with acute respiratory distress syndrome, requiring intubation and mechanical ventilation with many dying,” said Dr. Gelijns, who is also the Edmond A. Guggenheim Professor of Health Policy at the Icahn School of Medicine at Mount Sinai. “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.”
“We are interested to study the potential of this anti-inflammatory cell therapy to make an impact on the high mortality of lung complications in Covid-19 patients,” said CSTN Chairman A. Marc Gillinov, MD. “This randomized controlled trial is in line with our mandate to rigorously evaluate novel therapies for public health imperatives.”
Mesoblast
Mesoblast applies mesenchymal stem cells for this treatment. They derive the stem cells from bone marrow. In addition, they used the therapy in a phase 3 trial in children who suffered from an often-fatal inflammatory condition called graft-versus-host disease (GVHD), that may happen after bone marrow transplants. A cytokine storm hits these patients with GVHD. Covid-19 impacts patients in a similar way by damaging the lungs and other organs.
Mesenchymal Stem Cells
Dr. John Levine is Professor of Medicine (Hematology and Medical Oncology), and Pediatrics, at the Icahn School of Medicine at Mount Sinai. He has played a key role in the compassionate use of this treatment at Mount Sinai.
“These stem cells have shown excellent response rates in severe graft-versus-host disease in children,” said Dr. Levine, who is also the co-director of the Mount Sinai Acute GVHD International Consortium (MAGIC). “Mesenchymal stem cells have a natural property that dampens excessive immune responses.”