The FDA has approved Ryoncil, a mesenchymal stromal cell therapy, for treating steroid-refractory acute graft-versus-host disease in pediatric patients aged 2 months and older. Ryoncil is the first FDA-approved MSC therapy derived from healthy adult human donors and used for treating SR-aGVHD in patients who have undergone allogeneic hematopoietic stem cell transplantation. The safety and efficacy of Ryoncil was demonstrated in a multicenter study involving 54 pediatric patients, with 30 percent showing a complete response and 41 percent showing a partial response. Common adverse reactions included infections, fevers, and abdominal pain. Approval was granted to Mesoblast for Ryoncil.
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FDA approves Ryoncil for steroid-refractory acute graft-versus-host after allo-HSCT
