A Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease

This study is a phase 1, single-arm, safety and tolerability study of human TH-SC01 cell injection for perianal fistulas in Crohn's Disease.

Inclusion criteria

• 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.
• Subjects with perianal fistula confirmed by clinical assessment and MRI.
• Subjects aged between 18 and 70, both male and female.
• All subjects and their partners were not planning to have a child from screening to the end of the trial and agreed to use effective non-drug contraception during the trial.
• Subjects failed to respond to adequate treatment with any of the conventional antibiotics, immunomodulatory drugs (including steroids), anti-tumor necrosis factor-α (TNF-α) monoclonal antibodies and other biological agents.

Exclusion criteria

• Subjects with active infection evaluated by the investigator.
• Subjects with Crohn's disease requiring immediate therapy.
• Subjects with abscess or collections >2 cm.
• Subjects with rectal and/or anal stenosis and/or active proctitis.
• Subjects who treated with systemic steroids in the 4 weeks prior to stem cells administration.
• Subjects with abnormal laboratory results: liver function: total bilirubin >=1.5 × ULN, and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >=2 × ULN; renal function: creatinine clearance below 60 mL/minute calculated using Cockcroft-Gault formula or by serum creatinine >=1.5 × upper limit of normal (ULN).
• Subjects with malignant tumors or a history of malignant tumors.
• Subjects with severe, progressive, uncontrolled hepatic, hematological, gastrointestinal (except Crohn's disease), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral diseases.
• Serum virology test (HBeAg, HCV antibody, HIV antibody, Treponema pallidum antibody) positive.
• Subjects allergic to gentamicin sulfate, anesthetics or contrast media.
• Subjects allergic to MRI contrast.
• Subjects who has received stem cells in a previous clinical study or as a therapeutic agent.
• Subjects who has major surgery or severe trauma within 6 months prior to the screening period.
• Subjects who has received any investigational drug within 3 months prior to the screening.
• Subjects deemed inappropriate by the investigator to participate in this clinical trial.
• The female participant who is pregnant, or is lactating.