RecruitingPhase 1NCT06429241

Evaluate the Distribution and Dynamic Behavior of TH-SC01 Cells in Vivo in Patients With Perianal Fistula

A Phase I Clinical Study Evaluating the Distribution and Dynamic Behavior of Nuclide Labeled TH-SC01 Cells in Vivo in Patients With Perianal Fistula


Sponsor

Jiangsu Topcel-KH Pharmaceutical Co., Ltd.

Enrollment

8 participants

Start Date

Apr 8, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with perianal fistula


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a cell therapy called TH-SC01 — made from stem cells — to treat perianal fistulas (abnormal tunnels near the anus) in people with Crohn's disease or complex perianal fistulas. The study also uses special PET/CT imaging to track where the cells go in the body after injection. **You may be eligible if...** - You have been diagnosed with Crohn's disease or a complex perianal fistula for at least 6 months - You have an active fistula with 1–2 internal openings and up to 3 external openings - Your Crohn's disease is active in the fistula area but not causing severe bowel symptoms - You have previously tried antibiotics, immune-modifying drugs, anti-TNF biologics, or other biologics without adequate improvement - You are not planning to have children during the trial **You may NOT be eligible if...** - You have an active infection - You have a large abscess (more than 2 cm) near the fistula - You have severe rectal or anal narrowing or active rectal inflammation - You have received systemic steroids in the past 4 weeks - You have liver or kidney function problems beyond acceptable limits - You have had or have cancer - You have had a stem cell therapy previously - You have had major surgery or serious trauma in the past 6 months - You are pregnant or breastfeeding - You cannot undergo PET/CT scanning 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

BIOLOGICALMesenchymal Stem Cells (MSCs)

single dose injection (120 million cells)


Locations(1)

The first Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

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NCT06429241


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