Remestemcel, sold under the brand name Ryoncil, is an allogeneic bone marrow-derived mesenchymal stromal cell therapy used to treat graft-versus-host disease. The cells are isolated from the bone marrow of healthy adult human donors, and mesenchymal stromal cells can play various roles in the body and differentiate into several other cell types. The most common adverse reactions include viral and bacterial infectious disorders, pyrexia, hemorrhage, edema, abdominal pain and hypertension. It was approved for medical use in the United States in December 2024 and is the first mesenchymal stromal cell therapy approved by the US Food and Drug Administration.
Facts
Drug ClassMesenchymal stromal cell (MSC) therapy 2 Mechanism of ActionMesenchymal stromal cells secrete anti-inflammatory cytokines that lessen the inflammation caused by acute graft versus host disease 2 Approved UseSteroid-refractory acute graft versus host disease in pediatric patients 2 months of age and older 2 First Approved / Isolated Year Significant RiskMost common side effects, occurring in at least 20% of patients, included bacterial infectious disorders 3 Prescription Status Classification
Approval Status Route of Administration Connections
Long-Form Articles
Treats
Source Remestemcel (Wikipedia)
Sources
1. Remestemcel (Wikipedia)
Lead section
Remestemcel was approved for medical use in the United States in December 2024.
Treats: Graft-Versus-Host Disease, Lead section [treats]
used for the treatment of graft-versus-host disease
View the Source2. First-in-class Cell Therapy for Steroid-refractory Graft Versus Host Disease (AACR)
Body, description of the therapy
Remestemcel-L-rknd is a mesenchymal stromal cell (MSC) therapy.
Body, mechanism paragraph
MSCs secrete anti-inflammatory cytokines that can lessen the inflammation caused by aGVHD.
Body, approval paragraph
pediatric patients 2 months of age and older who have steroid-refractory acute graft versus host disease
Body, dosing paragraph
administered as an intravenous infusion twice a week for four consecutive weeks.
View the Source3. Ryoncil Receives FDA Approval for Children With GVHD (CURE)
Body, adverse reactions paragraphQuote, Body, adverse reactions paragraph
The most common side effects, which occurred in at least 20% of patients, included bacterial infectious disorders,
4. U.S. Food and Drug Administration (openFDA): openFDA drug labels naming Remestemcel by product type
U.S. Food and Drug Administration (openFDA)count by product typeQuote, count by product type
"term": "HUMAN PRESCRIPTION DRUG", "count": 1
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