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.
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.
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.