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

U.S. Food and Drug Administration

Published Dec 18, 2024accessed Sep 18, 2026Updated Sep 19, 2026
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https://www.fda.gov/news-events/press-announcements/fda-approves-first-mesenchymal-stromal-cell-therapy-treat-steroid-refractory-acute-graft-versus-host

fda.gov

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Cited by (2)

FactAdult Stem Cell: First FDA-approved mesenchymal stromal cell therapy = Ryoncil (remestemcel-L-rknd, Mesoblast), approved 18 Dec 2024 for steroid-refractory acute GVHD in patients aged 2 months and older. Its cells come from the bone marrow of healthy adult donorsFactAdult Stem Cell: Labeled risks (Ryoncil) = Hypersensitivity and acute infusion reactions, transmission of infectious disease, and ectopic tissue formation