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

Exclusion Criteria

• •1. Subjects with active infection evaluated by the investigator.
• •2. Subjects with Crohn's disease requiring immediate therapy.
• •3. Subjects with abscess or collections \>2 cm.
• •4. Subjects with rectal and/or anal stenosis and/or active proctitis.
• •5. Subjects who treated with systemic steroids in the 4 weeks prior to stem cells administration.
• •6. 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).
• •7. Subjects with malignant tumors or a history of malignant tumors.
• •8. Subjects with severe, progressive, uncontrolled hepatic, hematological, gastrointestinal (except Crohn's disease), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral diseases.
• •9. Serum virology test (HBeAg, HCV antibody, HIV antibody, Treponema pallidum antibody) positive.
• •10. Subjects allergic to gentamicin sulfate, anesthetics or contrast media.
• •11. Subjects allergic to MRI contrast.
• •12. Subjects who has received stem cells in a previous clinical study or as a therapeutic agent.
• •13. Subjects who has major surgery or severe trauma within 6 months prior to the screening period.
• •14. Subjects who has received any investigational drug within 3 months prior to the screening.
• •15. Subjects deemed inappropriate by the investigator to participate in this clinical trial.
• •16. The female participant who is pregnant, or is lactating.