Actively Recruiting
Phase 3 Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease
Led by Jiangsu Topcel-KH Pharmaceutical Co., Ltd. · Updated on 2025-04-13
228
Participants Needed
1
Research Sites
170 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Phase 3 Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Diagnosed with Crohn's disease at least 6 months prior according to Chinese guidelines
- Active perianal fistula with non-active luminal Crohn's Disease (CDAI 60 200)
- Maximum of 2 internal fistula openings and 3 external openings confirmed by clinical exam and MRI
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- American Society of Anesthesiologists (ASA) physical status grade I to II
- Agreement to use effective non-drug contraception during the trial for participants and their partners
You will not qualify if you...
- Allergy to human serum albumin, platelet lysate, gentamicin sulfate, anesthetic drugs, or MRI contrast agents
- Active infection
- Active Crohn's disease before treatment or incomplete induction phase treatment
- Abscess or fluid collection larger than 2 cm
- Rectal or anal stenosis limiting surgery
- Concurrent active proctitis
- Other fistulas such as rectum-vaginal or rectum-bladder fistulas
- History of diverting stoma surgery not reversed at least 1 month before treatment
- Planned perianal surgery during the trial for conditions other than anal fistula
- Abnormal liver or kidney function tests beyond specified limits
- Positive serum tests for hepatitis B, hepatitis C, HIV, or syphilis
- Current or past malignant tumors
- Congenital or acquired immunodeficiency
- Contraindications to MRI
- Severe or uncontrolled diseases of major organs
- Stem cell treatment within 2 years prior
- Ongoing or recent steroid use within 4 weeks
- Major surgery within 1 month before treatment or planned during the study
- History of drug abuse or alcoholism as defined by study criteria
- Pregnancy or breastfeeding
- Other conditions or factors deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
J
Jueyu Xia, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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