drugset / Trial / NCT00698191
Mesenchymal Stem Cells Transplantation for Refractory Systemic Lupus Erythematosus (SLE)
Phase 1/2
Unknown
20 enrolled
Nanjing Medical University
National Natural Science Foundation of China · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This study will explore a new approach to treat patients with a medical condition known as systemic lupus erythematosus (SLE) who have been resistant to previous treatments using a new population of cells with capability to restore a normal immune system that will no longer attack the body. The stated hypothesis is that the SLE condition is caused by an abnormal immune system that can be restored by replenishing the body with a new population of progenitor cells.
Timeline
- Start
- 2007-03
- Primary completion
- 2011-12
- Completion
- 2012-12
Publications
- Background Jiang B, Sun L, Hao S, Li X, Xu Y, Hou Y. Estrogen modulates bone marrow-derived DCs in SLE murine model-(NZB x NZW) F1 female mice. Immunol Invest. 2008;37(3):227-43. doi: 10.1080/08820130801973328.
- Background Jiang B, Sun L, Hao S, Li X, Hou Y. Estrogen distinctively modulates spleen DC from (NZB x NZW) F1 female mice in various disease development stages. Cell Immunol. 2007 Aug;248(2):95-102. doi: 10.1016/j.cellimm.2007.10.004. Epub 2007 Dec 3.
- Background Sun LY, Zhang HY, Feng XB, Hou YY, Lu LW, Fan LM. Abnormality of bone marrow-derived mesenchymal stem cells in patients with systemic lupus erythematosus. Lupus. 2007;16(2):121-8. doi: 10.1177/0961203306075793.
- Zheng Y, Liu S, Zeng L, Luo Y, Jin Z, Yang D, Shi Y, Li J, Wang H, Feng X, Wang D, Sun L. Allogeneic umbilical cord-derived mesenchymal stromal cells for treatment of refractory lupus nephritis: a real-world study. Stem Cell Res Ther. 2026 Apr 18;17(1):201. doi: 10.1186/s13287-026-05021-5.
- Liang J, Zhang H, Kong W, Deng W, Wang D, Feng X, Zhao C, Hua B, Wang H, Sun L. Safety analysis in patients with autoimmune disease receiving allogeneic mesenchymal stem cells infusion: a long-term retrospective study. Stem Cell Res Ther. 2018 Nov 14;9(1):312. doi: 10.1186/s13287-018-1053-4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Allogeneic MSC | Cell therapy | 106 cells/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 0.8 g | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 1.8 g | Intravenous |