{"entity":{"id":"remestemcel-l","kind":"drug","name":"Remestemcel-L","aka":[],"tldr":"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.","status":"approved","asOf":"2026-09-24","links":[{"label":"MSB-GVHD001 (Biol Blood Marrow Transplant 2020)","url":"https://doi.org/10.1016/j.bbmt.2020.01.018"},{"label":"Ryoncil label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a4e0918f-7444-4694-adeb-d38d98345659"},{"label":"FDA approval announcement (December 2024)","url":"https://www.fda.gov/news-events/press-announcements/fda-approves-first-mesenchymal-stromal-cell-therapy-treat-steroid-refractory-acute-graft-versus-host"}],"tags":[],"related":[],"cancers":[],"sections":["cell-therapy","supportive-care"],"technologies":["gvhd-ruxolitinib-steroid-refractory"],"targets":[],"drugs":[],"companies":["mesoblast"],"institutions":[],"pathways":[],"terms":["gvhd"],"trials":["msb-gvhd001"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Ryoncil","modality":"Allogeneic bone marrow-derived mesenchymal stromal cell therapy","supportive":true,"mechanism":"Mesenchymal stromal cells secrete anti-inflammatory factors and suppress activated T cells, reducing tissue damage in acute graft-versus-host disease.","approvals":[{"region":"US","year":2024,"indication":"Steroid-refractory acute graft-versus-host disease in children aged two months and older"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/remestemcel-l/","neighbours":{"section":[{"id":"cell-therapy","kind":"section","name":"Cell Therapy","route":"/fronts/cell-therapy/"},{"id":"supportive-care","kind":"section","name":"Supportive Care & Survivorship","route":"/fronts/supportive-care/"}],"technology":[{"id":"gvhd-ruxolitinib-steroid-refractory","kind":"technology","name":"When steroids fail: ruxolitinib for steroid-refractory GvHD","route":"/technologies/gvhd-ruxolitinib-steroid-refractory/"}],"company":[{"id":"mesoblast","kind":"company","name":"Mesoblast","route":"/companies/mesoblast/"}],"term":[{"id":"gvhd","kind":"term","name":"Graft-versus-host disease (GVHD) and graft-versus-leukaemia","route":"/terms/gvhd/"}],"trial":[{"id":"msb-gvhd001","kind":"trial","name":"MSB-GVHD001","route":"/trials/msb-gvhd001/"}],"paper":[{"id":"paper-msb-gvhd001-bbmt-2020","kind":"paper","name":"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","route":"/key-papers/paper-msb-gvhd001-bbmt-2020/"}]}}