The US FDA has approved remestemcel-L for steroid-refractory acute graft-vs-host disease in children 2 months and older. This is the first MSC product approved by the FDA. The treatment was found effective in a phase 3 study with 30% of participants having a complete response and 41% having a partial response. Common adverse reactions include infections and fever. Precautions include monitoring for reactions during infusion and contraindications for patients with known hypersensitivity. The treatment had orphan-drug, fast-track, and priority-review status and will be available in the US at transplant centers. The approval marks a milestone in innovative cell-based therapies for life-threatening diseases in children.
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FDA OKs Mesenchymal Stromal Cell Therapy for GVHD
