drugset / Trial / NCT05677672
The Purpose of This Study is to Evaluate the Safety and Efficacy of Human TH-SC01 Cell Injection in the Treatment of Complex Perianal Fistula
Phase 1/2
Unknown
84 enrolled
Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
Xiangya Hospital of Central South University · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to evaluate the safety and efficacy of human TH-SC01 cell injection for the treatment of complex perianal fistulas
Timeline
- Start
- 2022-12-30
- Primary completion
- 2023-08-30
- Completion
- 2023-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TH-SC01 | Cell therapy | 6e+06 cells/kg | — |
| Subject | TH-SC01 | Cell therapy | 1.2e+08 cells/kg | — |
| Subject | TH-SC01 | Cell therapy | 1.8e+08 cells/kg | — |