NCT06925594

Phase 3 Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease

A Randomized, Double-blind, Placebo-controlled, Multi-center Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Human TH-SC01 Cell Injection in the Treatment of Anal Fistulas in Patients With Non-active/Mildly Active Crohn's Disease

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 228 (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 efficacy of human TH-SC01 cell injection for the treatment of perianal fistulas in Crohn's Disease over 24 weeks.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
OTHER	Human TH-SC01 cell injection	Human TH-SC01 cell injection is a cell suspension in aseptic buffered solution containing human expanded umbilical cord-derived stem cells of allogeneic origin in disposable vials with no preservative agents. The cells will be given at a dose of 120 million cells (5 million cells / mL) for intralesional injection.
OTHER	Saline solution	Placebo (saline solution) will be given also for intralesional injection at the same quantity (volume, 24 mL) and following the same schedule.

Timeline

• Start date: 2025-03-20
• Primary completion: 2026-12-28
• Completion: 2028-06-28
• First posted: 2025-04-13
• Last updated: 2025-04-13

Locations

1 site across 1 country: China