Trial – MesenCell Bone Marrow Stem Cells Evaluated in Chronic Graft-Versus-Host Disease
This Phase I, single-arm study plans to enroll 20 adults with steroid-refractory moderate or severe disease to receive up to three intravenous infusions alongside standard therapy.
Trial at a glance
- Sponsor: Pontifícia Universidade Católica do Paraná, Brazil
- Phase/Status: Phase 1; not yet recruiting
- Indication: Moderate or severe chronic graft-versus-host disease refractory to corticosteroid treatment in approximately 20 adults
- Arms/Dosing: MesenCell: one to three intravenous infusions of bone marrow-derived mesenchymal stem cells at 2 × 10⁶ cells/kg, administered at seven-day intervals. The number of infusions will depend on the assigned dose-escalation level. MesenCell will be given with standard treatment consisting of corticosteroids at 1 mg/kg/day and cyclosporine.
- Control: None
- Endpoints: Primary: number of participants with treatment-related adverse events within 30 days after the last MesenCell infusion. Secondary: overall treatment response rate at six months after treatment initiation; change from baseline in overall response through 12 months after treatment initiation.
- Timing: Estimated start: October 2026; estimated primary completion: September 2028; estimated study completion: October 2028
Trial Summary
ClinicalTrials.gov lists the following summary for the linked study.
This is a prospective, single-arm, open-label Phase I clinical trial designed to evaluate the safety and treatment response of bone marrow-derived mesenchymal stem cells (MesenCell) in adult patients with moderate or severe chronic graft-versus-host disease (cGVHD) refractory to corticosteroid treatment.
Approximately 20 participants will be enrolled in the study. Participants will receive one to three intravenous infusions of MesenCell at a dose of 2 × 10⁶ cells/kg, administered at seven-day intervals. The number of infusions will depend on the dose-escalation level to which each participant is assigned.
MesenCell will be administered in combination with standard treatment consisting of corticosteroids at a dose of 1 mg/kg/day and cyclosporine. Participants will undergo clinical and laboratory monitoring throughout the study to evaluate the safety of the intervention and the occurrence, frequency, severity, and causal relationship of adverse events following MesenCell infusion.
Treatment response will be assessed using standardized criteria for chronic graft-versus-host disease, including overall and organ-specific response. The study will also evaluate all-cause mortality, failure-free survival, and changes in corticosteroid and immunosuppressive medication use, including dose reductions, treatment discontinuation, and reduction in the number of immunosuppressive agents.
Participants will be followed for 12 months after administration of the last MesenCell dose. During this period, clinical assessments and review of medical records will be performed to monitor treatment response, disease progression, safety outcomes, need for additional systemic therapy, mortality, and changes in concomitant immunosuppressive treatment.
- Contact: Carmen L K Rebelatto, PhD; carmen.rebelatto@pucpr.br; +554132711858
- Contact: Lidiane M. B. Leite, PhD; lidiane.leite@pucpr.br; +554132711858
- Contact: Vaneuza M Funke; vfunke@gmail.com; 5541999627985
- Contact: Vaneuza A M Funke; gahe.pesquisaclinica@gmail.com; 4199277235
- Contact: João S H Farias; jshfarias@gmail.com; 4199846033
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