Status: Not yet recruiting
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Trial of Remestemcel-L-rknd Added to Ruxolitinib for Grade III-IV Steroid-Refractory Acute Graft-Versus-Host Disease
This study is a randomized, double-blind, placebo-controlled, multicenter Phase III trial to compare the efficacy and safety of remestemcel-L-rknd (remestemcel-L), ex-vivo cultured adult human mesenchymal stromal cells (MSC), combined with ruxolitinib vs. ruxolitinib combined with placebo as second-line therapy in adult patients with Grade III-IV steroid-refractory acute graft-versus-host disease (SR-aGVHD).
Participants needed: 180
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Mesoblast, Ltd.Updated: May 5, 2026
Eligibility criteria
Age 18 years or older at the time of enrollment. [+13]
Underwent second allogeneic hematopoietic cell transplantation within six months... [+15]