drugset / Trial / NCT02291770
Treatment of Chronic Graft-Versus-Host Disease With Mesenchymal Stromal Cells
Phase 3
Unknown
130 enrolled
Guangdong Provincial People's Hospital
Academy Military Medical Science, China · collabGuangzhou First People's Hospital · collabGuangzhou General Hospital of Guangzhou Military Command · collabNanfang Hospital, Southern Medical University · collabSun Yat-sen University · collabThird Affiliated Hospital, Sun Yat-Sen University · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Chronic Graft-versus-Host Disease (cGvHD) is a potentially lethal disorder. A variety of second line immunosuppressive agents have been investigated but no optimal treatment has emerged. There is therefore a need for novel treatment strategies. Mesenchymal stromal cells (MSC) exhibit immunomodulatory properties and a recent pilot study suggests a response rate of 70% in steroid- refractory patients. In the present randomized study the efficacy and safety of MSC treatment will be further studied in patients with cGvHD.
Timeline
- Start
- 2014-10
- Primary completion
- 2015-11
- Completion
- 2019-12
Publications
- Background Weng J, He C, Lai P, Luo C, Guo R, Wu S, Geng S, Xiangpeng A, Liu X, Du X. Mesenchymal stromal cells treatment attenuates dry eye in patients with chronic graft-versus-host disease. Mol Ther. 2012 Dec;20(12):2347-54. doi: 10.1038/mt.2012.208. Epub 2012 Oct 16.
- Background Weng JY, Du X, Geng SX, Peng YW, Wang Z, Lu ZS, Wu SJ, Luo CW, Guo R, Ling W, Deng CX, Liao PJ, Xiang AP. Mesenchymal stem cell as salvage treatment for refractory chronic GVHD. Bone Marrow Transplant. 2010 Dec;45(12):1732-40. doi: 10.1038/bmt.2010.195. Epub 2010 Sep 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | mesenchymal stem cells | Cell therapy | 2e+06 cells/kg | Intravenous |