RecruitingPhase 3NCT06925594

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


Sponsor

Jiangsu Topcel-KH Pharmaceutical Co., Ltd.

Enrollment

228 participants

Start Date

Mar 20, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This Phase 3 study is testing TH-SC01 — an injection of specialised stem cells — to heal perianal fistulas (abnormal tunnels near the anus) in people with Crohn's disease. These fistulas are notoriously difficult to treat and can significantly affect quality of life. **You may be eligible if...** - You are 18 or older with a confirmed Crohn's disease diagnosis for at least 6 months - You have active perianal fistulas (up to 2 fistula tracts and 3 external openings) - Your Crohn's disease in the rest of your gut is not currently flaring up severely (CDAI score ≤ 200) - Your general health is good (ECOG 0–1, low anaesthetic risk) **You may NOT be eligible if...** - Your fistulas are very complex or involve more tracts than the criteria allow - You are pregnant or planning to have children during the trial - You have active infections or other serious medical conditions - Your luminal (gut) Crohn's disease is currently active Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERHuman 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.

OTHERSaline solution

Placebo (saline solution) will be given also for intralesional injection at the same quantity (volume, 24 mL) and following the same schedule.


Locations(1)

Jiangsu Topcel-KH Pharmaceutical Co., Ltd.

Nanjing, Jiangsu, China

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NCT06925594


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