Remestemcel-L, is an allogeneic, ex vivo culture-expanded, bone marrow-derived mesenchymal stromal cell (MSC) therapy.
It is marketed under the brand name RYONCIL (remestemcel-l-rknd) and is indicated for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGvHD) in pediatric patients 2 months of age and older.
The product consists of MSCs isolated from healthy adult donors, formulated as a frozen cell suspension for intravenous administration.
The recommended dosage is \(2 \times 10^6\) MSCs/kg body weight per intravenous infusion, administered twice weekly for 4 consecutive weeks (total of 8 infusions), with at least 3 days between infusions.
Clinical response is assessed 28 ± 2 days after the first dose.