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).

NCT Number	NCT07568535
Lead Sponsor	Mesoblast, Ltd.
Conditions	GVHD - Graft-Versus-Host Disease
Enrollment	180 participants
Start Date	2026-08-31
Primary Completion	2028-02-28 (estimated)
Study Completion	2028-07 (estimated)
Updated on ClinicalTrials.gov	2026-05-05