Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT06925594
Status:
RECRUITING
Last Update Posted:
2025-04-13
First Post:
2025-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 3 Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease
Sponsor:
Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: