drugset / Trial / NCT03174587
Evaluate the Safety of CS20AT04 Inj. in Subjects With Lupus Nephritis
NaSingle-groupOpen-labelTreatment
Summary
The purpose of conducting phase 1 trial to evaluate the safety and tolerability of allogenic bone marrow-derived mesenchymal stem cells(CS20AT04) in subjects with lupus nephritis. Evaluating DLT by IV injection according to dose-escalating in lupus nephritis patients.
Timeline
- Start
- 2017-05-30
- Primary completion
- 2019-03-12
- Completion
- 2019-08-19
Publications
- Background Jang E, Jeong M, Kim S, Jang K, Kang BK, Lee DY, Bae SC, Kim KS, Youn J. Infusion of Human Bone Marrow-Derived Mesenchymal Stem Cells Alleviates Autoimmune Nephritis in a Lupus Model by Suppressing Follicular Helper T-Cell Development. Cell Transplant. 2016;25(1):1-15. doi: 10.3727/096368915X688173. Epub 2015 May 13.
- Background Shim JS, Sung YK, Joo YB, Lee HS, Bae SC. Prevalence and incidence of systemic lupus erythematosus in South Korea. Rheumatol Int. 2014 Jul;34(7):909-17. doi: 10.1007/s00296-013-2915-9. Epub 2013 Dec 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CS20AT04 | Cell therapy | 1e+06 cells/kg | Intravenous |
| Subject | CS20AT04 | Cell therapy | 2e+06 cells/kg | Intravenous |
| Subject | CS20AT04 | Cell therapy | 3e+06 cells/kg | Intravenous |