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.
Parallel
Human TH-SC01 cell injection
Other interventionHuman TH-SC01 cell injection is a cell suspension in aseptic buffered solution containing human expanded umbilical cord-derived stem cells of allogeneic origin in disposable vials with no preservative agents. The cells will be given at a dose of 120 million cells (5 million cells / mL) for intralesional injection.
Saline solution
Other interventionPlacebo (saline solution) will be given also for intralesional injection at the same quantity (volume, 24 mL) and following the same schedule.
The proportion of subjects achieved combined remission
Combined Remission of perianal fistulising Crohn's disease defined as the all treated external openings achieved clinical remission at week 24， and absence of collections \> 2 cm of the treated perianal fistulas confirmed by centrally blinded MRI assessment by week 24.
The proportion of subjects achieved clinical remission
Clinical Remission defined as closure of all treated external openings that were draining at baseline despite gentle finger compression, and no obvious fistulas can be felt by digital examination，as clinically assessed.
The proportion of subjects achieved a clinical response
Clinical response defined as closure of at least 50% of all treated external openings that were draining at baseline, as clinically assessed
The proportion of subjects recurrence
Recurrence defined as the reopening of the closed external openings that had achieved clinical remission after treatment, the appearance of spontaneous fluid drainage, or the presence of fistulas with fluid collections \> 2 cm as assessed by enhanced pelvic MRI
Time to achieve clinical remission, clinical response and recurrence
Time to achieve clinical remission, clinical response and recurrence within 24 weeks after drug administration.
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