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FDA Approves First Mesenchymal Stromal Cell Therapy …

FDA Approves First Mesenchymal Stromal Cell Therapy to Treat Steroid-refractory Acute Graft-versus-host Disease

The FDA has approved Ryoncil (remestemcel-L), the first mesenchymal stromal cell (MSC) therapy for treating steroid-refractory acute graft-versus-host disease (SR-aGVHD) in pediatric patients aged two months and older. This approval, announced on December 18, 2024, marks a significant milestone in cell-based therapies for severe conditions like GVHD, which can have devastating effects on patients, particularly children[1][2][4]. Ryoncil is derived from healthy donor bone marrow and has demonstrated a 70% overall response rate in clinical trials[3][5].

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