drugset / Trial / NCT05631717
The Study of Comparing the Efficacy and Safety of Human Umbilical Cord MSCs and Low-dose IL-2 in the Treatment of LN
Phase 3
Unknown
40 enrolled
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to compare the efficacy and safety of human umbilical cord mesenchymal stem cells and low-dose IL-2 in the treatment of LN
Timeline
- Start
- 2022-10-01
- Primary completion
- 2025-06
- Completion
- 2025-12-31
Publications
- Background Geng L, Xu X, Zhang H, Chen C, Hou Y, Yao G, Wang S, Wang D, Feng X, Sun L, Liang J. Comprehensive expression profile of long non-coding RNAs in Peripheral blood mononuclear cells from patients with neuropsychiatric systemic lupus erythematosus. Ann Transl Med. 2020 Mar;8(6):349. doi: 10.21037/atm.2020.03.25.
- Background 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.
- Background Zhang H, Liang J, Qiu J, Wang F, Sun L. Ultrasonographic evaluation of enthesitis in patients with ankylosing spondylitis. J Biomed Res. 2017 Jan 19;31(2):162-169. doi: 10.7555/JBR.31.20160088.
- Background Zhang H, Liang J, Tang X, Wang D, Feng X, Wang F, Hua B, Wang H, Sun L. Sustained benefit from combined plasmapheresis and allogeneic mesenchymal stem cells transplantation therapy in systemic sclerosis. Arthritis Res Ther. 2017 Jul 19;19(1):165. doi: 10.1186/s13075-017-1373-2.
- Background Liang J, Zhang H, Zhao C, Wang D, Ma X, Zhao S, Wang S, Niu L, Sun L. Effects of allogeneic mesenchymal stem cell transplantation in the treatment of liver cirrhosis caused by autoimmune diseases. Int J Rheum Dis. 2017 Sep;20(9):1219-1226. doi: 10.1111/1756-185X.13015. Epub 2017 Feb 20.
- Background Chen C, Liang J, Yao G, Chen H, Shi B, Zhang Z, Zhao C, Zhang H, Sun L. Mesenchymal stem cells upregulate Treg cells via sHLA-G in SLE patients. Int Immunopharmacol. 2017 Mar;44:234-241. doi: 10.1016/j.intimp.2017.01.024. Epub 2017 Jan 25.
- Background Liang J, Wang F, Wang D, Zhang H, Zhao C, Wang S, Sun L. Transplantation of mesenchymal stem cells in a laryngeal carcinoma patient with radiation myelitis. Stem Cell Res Ther. 2015 Nov 4;6:213. doi: 10.1186/s13287-015-0203-1.
- Background Liang J, Sun L. Mesenchymal stem cells transplantation for systemic lupus erythematosus. Int J Rheum Dis. 2015 Feb;18(2):164-71. doi: 10.1111/1756-185X.12531. Epub 2015 Jan 22.
- Background Liang J, Zhang H, Wang D, Feng X, Wang H, Hua B, Liu B, Sun L. Allogeneic mesenchymal stem cell transplantation in seven patients with refractory inflammatory bowel disease. Gut. 2012 Mar;61(3):468-9. doi: 10.1136/gutjnl-2011-300083. Epub 2011 May 26. No abstract available.
- Background Liang J, Li X, Zhang H, Wang D, Feng X, Wang H, Hua B, Liu B, Sun L. Allogeneic mesenchymal stem cells transplantation in patients with refractory RA. Clin Rheumatol. 2012 Jan;31(1):157-61. doi: 10.1007/s10067-011-1816-0. Epub 2011 Aug 12.
- Background Liang J, Zhang H, Hua B, Wang H, Lu L, Shi S, Hou Y, Zeng X, Gilkeson GS, Sun L. Allogenic mesenchymal stem cells transplantation in refractory systemic lupus erythematosus: a pilot clinical study. Ann Rheum Dis. 2010 Aug;69(8):1423-9. doi: 10.1136/ard.2009.123463.
- Background Liang J, Gu F, Wang H, Hua B, Hou Y, Shi S, Lu L, Sun L. Mesenchymal stem cell transplantation for diffuse alveolar hemorrhage in SLE. Nat Rev Rheumatol. 2010 Aug;6(8):486-9. doi: 10.1038/nrrheum.2010.80. Epub 2010 Jun 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | aldesleukin | Protein / enzyme biologic | 1e+06 iu | Subcutaneous |
| Subject | human umbilical cord mesenchymal stem cells | Cell therapy | 1e+06 cells/kg | Intravenous |