drugset / Trial / NCT01765634
Mesenchymal Stem Cells for Treatment of Refractory Acute Graft-versus-host Disease
Phase 2
Unknown
40 enrolled
Nanfang Hospital, Southern Medical University
Guangdong Provincial People's Hospital · collabGuangzhou First People's Hospital · collabGuangzhou General Hospital of Guangzhou Military Command · collabPeking University People's Hospital · collabSouthern Medical University, China · collabSun Yat-Sen Memorial Hospital of Sun Yat-Sen University · collabSun Yat-sen University · collabThird Affiliated Hospital, Sun Yat-Sen University · collabZhongshan People's Hospital, Guangdong, China · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the utility of treating patients experiencing refractory acute graft-versus-host disease with ex-vivo-expanded BM-drived mesenchymal stem cells from third-party donors. The objective was to evaluate the effect and safety of such treatment on refractory acute graft-versus-host disease.
Timeline
- Start
- 2013-01
- Primary completion
- 2015-12
- Completion
- 2016-12
Publications
- Background Le Blanc K, Frassoni F, Ball L, Locatelli F, Roelofs H, Lewis I, Lanino E, Sundberg B, Bernardo ME, Remberger M, Dini G, Egeler RM, Bacigalupo A, Fibbe W, Ringden O; Developmental Committee of the European Group for Blood and Marrow Transplantation. Mesenchymal stem cells for treatment of steroid-resistant, severe, acute graft-versus-host disease: a phase II study. Lancet. 2008 May 10;371(9624):1579-86. doi: 10.1016/S0140-6736(08)60690-X.
- Background von Bonin M, Stolzel F, Goedecke A, Richter K, Wuschek N, Holig K, Platzbecker U, Illmer T, Schaich M, Schetelig J, Kiani A, Ordemann R, Ehninger G, Schmitz M, Bornhauser M. Treatment of refractory acute GVHD with third-party MSC expanded in platelet lysate-containing medium. Bone Marrow Transplant. 2009 Feb;43(3):245-51. doi: 10.1038/bmt.2008.316. Epub 2008 Sep 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | mesenchymal stem cells | Cell therapy | 1e+06 cells/kg | Intravenous |