NCT06925594
Phase 3 Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease
Recruiting · Phase 3 · Jiangsu Topcel-KH Pharmaceutical Co., Ltd. · registry updated 2025-04-13
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- Signed informed consent
- Subjects with Crohn's disease diagnosed at least 6 months earlier according to the Chinese Consensus Opinion on the Diagnosis and Treatment of Inflammatory Bowel Diseases (Beijing, 2018)
- Subjects with active perianal fistula and non active luminal CD defined by a CDAI ≤ 200.
- Presence of perianal fistulas with a maximum of 2 fistulas (internal openings) and a maximum of 3 external openings, assessed by clinical assessment and MRI.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- American Society of Anesthesiologists (ASA) physical status classification of grade I to grade II.
Exclusion
- Subjects allergic to human serum albumin, human platelet lysate, gentamicin sulfate, anesthetic drugs or MRI contrast agents.
- Subjects with active infection evaluated by the investigator
- Subjects with active Crohn's disease before drug administration or have not completed the induction-phase treatment.
- Subjects with abscess or collections \>2 cm.
- Rectal and/or anal stenosis , if this means a limitation for any surgical procedure
- Subjects with concurrent active proctitis.