drugset / Trial / NCT00603330
Mesenchymal Stem Cell Infusion as Treatment for Steroid-Resistant Acute Graft Versus Host Disease (GVHD) or Poor Graft Function
Phase 2
Unknown
100 enrolled
University of Liege
AZ Sint-Jan AV · collabCliniques universitaires Saint-Luc- Université Catholique de Louvain · collabJolimont Hospital Haine Saint Paul · collabKU Leuven · collabMaastricht University Medical Center · collabQueen Fabiola Children's University Hospital · collabUniversitair Ziekenhuis Brussel · collabUniversity Hospital of Mont-Godinne · collabUniversity Hospital, Antwerp · collabUniversity Hospital, Ghent · collabZiekenhuis Netwerk Antwerpen (ZNA) · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The present project aims at investigating the role of MSC for the treatment of patients with Part 1: Steroid-refractory grade II-IV acute GVHD. Part 2: Poor graft function (PGF) Part 3: Low or falling donor T-cell chimerism after allogeneic HCT. This is a multicenter phase II study examining the feasibility and efficacy of this approach.
Timeline
- Start
- 2008-01
- Primary completion
- 2024-08
- Completion
- 2024-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | mesenchymal stem cells | Cell therapy | 2e+06 cells/kg | Other |
| Subject | mesenchymal stem cells | Cell therapy | 4e+06 cells/kg | Other |