eligibility_summary
Eligibility: Children ≥28 days to <18 yrs (≥3.2 kg) post-allogeneic HSCT (non-malignant, hematologic malignancy, or neuroblastoma) with Grade II–IV steroid-refractory aGvHD, life expectancy >28 days, contraception/consent required. Exclude: disease relapse, HSCT for other solid tumors, overlap syndrome, non-steroid first-line aGvHD therapy, prior MSCs, pregnancy/breastfeeding, hypersensitivity to study/BAT drugs, interfering illness, uncontrolled infection, recent investigational drugs.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Interventions: MC0518 (investigational biological, allogeneic mesenchymal stromal cell infusion) vs Best Available Therapy: extracorporeal photopheresis (device-based cellular immunotherapy), anti-thymocyte globulin (polyclonal antibody), etanercept (TNF-receptor p75 Fc fusion protein), infliximab (anti–TNF-α monoclonal antibody), ruxolitinib (small-molecule JAK1/2 inhibitor). Mechanisms/targets: MC0518 delivers broad immunomodulation via paracrine factors (e.g., PGE2, TGF-β, IL-10, IDO) and cell contact to suppress alloreactive effector T cells/NK cells, induce Tregs, skew macrophages to M2, and render dendritic cells tolerogenic, dampens Th1/Th17 cytokines (IL-2, IFN-γ, TNF-α, IL-17). ECP creates apoptotic leukocytes that drive tolerogenic DCs and Treg expansion. ATG depletes T cells. Etanercept/infliximab neutralize TNF-α signaling. Ruxolitinib blocks JAK-STAT cytokine signaling (e.g., IL-2, IL-6, IFN-γ). Target pathways: TNF, JAK-STAT, T-cell activation/APC function, immune tolerance.