# Remestemcel-L

Source: https://onco.cc/drugs/remestemcel-l/  
OnCo record `remestemcel-l` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Donor bone marrow stromal cells given to children whose acute graft-versus-host disease no longer responds to steroids, the first mesenchymal stromal cell therapy approved in the United States.

## Summary

Remestemcel-L is a suspension of culture-expanded mesenchymal stromal cells from the bone marrow of healthy adult donors. The cells dampen the T-cell attack on skin, gut and liver that defines acute graft-versus-host disease after an allogeneic stem cell transplant. The FDA approved it in December 2024 for steroid-refractory acute graft-versus-host disease in children aged two months and older, on a single-arm trial in which most children responded within a month. It is given intravenously twice a week for four weeks and is the first mesenchymal stromal cell product approved in the United States.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-24
- Brand: Ryoncil
- Modality: Allogeneic bone marrow-derived mesenchymal stromal cell therapy
- Mechanism: Mesenchymal stromal cells secrete anti-inflammatory factors and suppress activated T cells, reducing tissue damage in acute graft-versus-host disease.
- Approvals: US 2024: Steroid-refractory acute graft-versus-host disease in children aged two months and older

## Sources

- MSB-GVHD001 (Biol Blood Marrow Transplant 2020): https://doi.org/10.1016/j.bbmt.2020.01.018
- Ryoncil label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a4e0918f-7444-4694-adeb-d38d98345659
- FDA approval announcement (December 2024): https://www.fda.gov/news-events/press-announcements/fda-approves-first-mesenchymal-stromal-cell-therapy-treat-steroid-refractory-acute-graft-versus-host

## Connected records

- fronts: [Cell Therapy](https://onco.cc/fronts/cell-therapy/), [Supportive Care & Survivorship](https://onco.cc/fronts/supportive-care/)
- technologies: [When steroids fail: ruxolitinib for steroid-refractory GvHD](https://onco.cc/technologies/gvhd-ruxolitinib-steroid-refractory/)
- companies: [Mesoblast](https://onco.cc/companies/mesoblast/)
- terms: [Graft-versus-host disease (GVHD) and graft-versus-leukaemia](https://onco.cc/terms/gvhd/)
- trials: [MSB-GVHD001](https://onco.cc/trials/msb-gvhd001/)
- key papers: [A phase 3, single-arm, prospective study of remestemcel-L, ex vivo culture-expanded adult human mesenchymal stromal cells for the treatment of pediatric patients who failed to respond to steroid treatment for acute graft-versus-host disease](https://onco.cc/key-papers/paper-msb-gvhd001-bbmt-2020/)

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