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 I/Ⅱ Study to Evaluate the Safety and Efficacy of Human TH-SC01 Cell Injection in the Treatment of Complex Perianal Fistula

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Jiangsu Topcel-KH Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Detailed description

This study is a phase Ⅰ/Ⅱ study, Phase 1 was the dose increment phase, and phase 2 was the expansion phase

Conditions

• Complex Perianal Fistulas

Interventions

Type	Name	Description
BIOLOGICAL	Human TH-SC01 Cell Injection	Single injection of 0.6×10\^7,1.2×10\^8, 1.8×10\^8 cells/kg
OTHER	Saline solution	saline solution will be given at the same quantity and following the same schedule

Timeline

• Start date: 2022-12-30
• Primary completion: 2023-08-30
• Completion: 2023-12-30
• First posted: 2023-01-10
• Last updated: 2023-01-10

Locations

1 site across 1 country: China