drugset / Trial / NCT01765660
Mesenchymal Stem Cells for Treatment of Refractory Chronic Graft-versus-host Disease
Phase 2
Unknown
60 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 chronic 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 chronic graft-versus-host disease.
Timeline
- Start
- 2013-01
- Primary completion
- 2015-12
- Completion
- 2016-12
Publications
- Background Perez-Simon JA, Lopez-Villar O, Andreu EJ, Rifon J, Muntion S, Diez Campelo M, Sanchez-Guijo FM, Martinez C, Valcarcel D, Canizo CD. Mesenchymal stem cells expanded in vitro with human serum for the treatment of acute and chronic graft-versus-host disease: results of a phase I/II clinical trial. Haematologica. 2011 Jul;96(7):1072-6. doi: 10.3324/haematol.2010.038356. Epub 2011 Mar 10.
- Background Ringden O, Uzunel M, Rasmusson I, Remberger M, Sundberg B, Lonnies H, Marschall HU, Dlugosz A, Szakos A, Hassan Z, Omazic B, Aschan J, Barkholt L, Le Blanc K. Mesenchymal stem cells for treatment of therapy-resistant graft-versus-host disease. Transplantation. 2006 May 27;81(10):1390-7. doi: 10.1097/01.tp.0000214462.63943.14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | mesenchymal stem cells | Cell therapy | 1e+06 cells/kg | Intravenous |