drugset / Trial / NCT02240992
MSCs With or Without Peripheral Blood Stem Cell for Treatment of Poor Graft Function and Delayed Platelet Engraftment
Phase 2/3
Unknown
120 enrolled
Nanfang Hospital, Southern Medical University
Academy Military Medical Science, China · collabGuangdong Provincial People's Hospital · collabGuangzhou First People's Hospital · collabGuangzhou General Hospital of Guangzhou Military Command · collabHuazhong University of Science and Technology · 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 · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to compare the efficacy of mesenchymal stem cells (MSCs) with or without granulocyte colony-stimulating factor (G-CSF) mobilized peripheral stem cells (PBSC) in treating patients experiencing poor graft function or delayed platelet engraftment after allogeneic hematopoietic stem cell transplantation.
Timeline
- Start
- 2014-09
- Primary completion
- 2018-09
- Completion
- 2018-12
Publications
- Background Sanchez-Guijo FM, Lopez-Villar O, Lopez-Anglada L, Villaron EM, Muntion S, Diez-Campelo M, Perez-Simon JA, San Miguel JF, Caballero D, del Canizo MC. Allogeneic mesenchymal stem cell therapy for refractory cytopenias after hematopoietic stem cell transplantation. Transfusion. 2012 May;52(5):1086-91. doi: 10.1111/j.1537-2995.2011.03400.x. Epub 2011 Oct 24.
- Background Meuleman N, Tondreau T, Ahmad I, Kwan J, Crokaert F, Delforge A, Dorval C, Martiat P, Lewalle P, Lagneaux L, Bron D. Infusion of mesenchymal stromal cells can aid hematopoietic recovery following allogeneic hematopoietic stem cell myeloablative transplant: a pilot study. Stem Cells Dev. 2009 Nov;18(9):1247-52. doi: 10.1089/scd.2009.0029.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PBSC | Unknown | 2e+08 cells/kg | Intravenous |
| Subject | mesenchymal stem cells | Cell therapy | 1e+06 cells/kg | Intravenous |