drugset / Trial / NCT00972660
Safety and Efficacy Study of Allogenic Mesenchymal Stem Cells to Treat Extensive Chronic Graft Versus Host Disease
RandomizedParallel-groupOpen-labelTreatment
Summary
Study Design: Treatment, Randomized, Open Label, Parallel Assignment,Safety/Efficacy Study. The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSC) expanded ex-vivo infusion for the treatment of patients who have developed a newly diagnosed extensive or refractory chronic graft versus host disease (chronic GVHD) to the usual therapeutic measures.
Timeline
- Start
- 2009-09
- Primary completion
- 2015-12
- Completion
- 2017-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mesenchymal stem cell | Cell therapy | 2e+06 cells/kg | Intravenous |
| Comparator | Cyclosporine | Peptide | — | — |
| Comparator | Methotrexate | Small molecule | — | — |
| Comparator | Mycophenolate Mofetil | Small molecule | — | — |
| Comparator | Prednisone | Other / unclassified | 1 mg/kg | — |
| Comparator | Tacrolimus | Small molecule | — | — |