drugset / Trial / NCT01468064
Autologous Bone Marrow Stromal Cell and Endothelial Progenitor Cell Transplantation in Ischemic Stroke
Phase 1/2
Completed
20 enrolled
Southern Medical University, China
Cellonis Biotechnology Co. Ltd. · collabThe First People's Hospital of Haizhu District Guangzhou · collabThe Second People's Hospital of Nanhai District of Foshan · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
The purpose of this study is to evaluate the feasibility, efficacy, and safety of autologous transplantation of ex vivo expanded bone marrow stromal cells (BMSCs)and endothelial progenitor cells (EPCs) for treatment of patients with ischemic stroke.
Timeline
- Start
- 2011-11
- Primary completion
- 2015-12
- Completion
- 2017-03
Publications
- Background Lee JS, Hong JM, Moon GJ, Lee PH, Ahn YH, Bang OY; STARTING collaborators. A long-term follow-up study of intravenous autologous mesenchymal stem cell transplantation in patients with ischemic stroke. Stem Cells. 2010 Jun;28(6):1099-106. doi: 10.1002/stem.430.
- Background Bang OY, Lee JS, Lee PH, Lee G. Autologous mesenchymal stem cell transplantation in stroke patients. Ann Neurol. 2005 Jun;57(6):874-82. doi: 10.1002/ana.20501.
- Fang J, Guo Y, Tan S, Li Z, Xie H, Chen P, Wang K, He Z, He P, Ke Y, Jiang X, Chen Z. Autologous Endothelial Progenitor Cells Transplantation for Acute Ischemic Stroke: A 4-Year Follow-Up Study. Stem Cells Transl Med. 2019 Jan;8(1):14-21. doi: 10.1002/sctm.18-0012. Epub 2018 Aug 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BMSCs | Cell therapy | 2.5e+06 cells/kg | Intravenous |
| Subject | EPCs | Cell therapy | 2.5e+06 cells/kg | Intravenous |