The US FDA has approved remestemcel-L, an allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy for treating steroid-refractory acute graft-versus-host disease (SR-aGVHD) in pediatric patients aged two months and older. Remestemcel-L is the first FDA-approved MSC therapy. Clinical evidence The safety and efficacy of remestemcel-L were evaluated in a clinical trial involving 54 pediatric patients with SR-aGVHD following an allogeneic hematopoietic stem cell transplant.
The drug demonstrated a complete response in 30% of patients and a partial response in 41% after 28 days of treatment. Dosage and administration IV infusions twice weekly Contraindications – Hypersensitivity to dimethyl sulfoxide or porcine and bovine proteins Warnings and precautions Hypersensitivity and acute infusion reactions Transmission of infectious agents Ectopic tissue formation Adverse reactions…
