NCT05626023

A Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease

A Phase I Study to Evaluate the Safety and Tolerability of Human TH-SC01 Cell Injection for the Treatment of Perianal Fistulas in Crohn's Disease

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• 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 tolerability of human TH-SC01 cell injection for the treatment of perianal fistulas in Crohn's Disease

Detailed description

This study is a phase 1, single-arm, safety and tolerability study of human TH-SC01 cell injection for perianal fistulas in Crohn's Disease.

Conditions

• Perianal Fistula
• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Human TH-SC01 cell injection	Single injection of human TH-SC01 cell injection

Timeline

• Start date: 2022-01-30
• Primary completion: 2023-08-30
• Completion: 2025-02-28
• First posted: 2022-11-23
• Last updated: 2025-04-01

Locations

1 site across 1 country: China