A Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's D… (NCT05626023) | Clinical Trial Compass
CompletedPhase 1/2
A Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease
China9 participantsStarted 2022-01-30
Plain-language summary
The purpose of this study is to evaluate the safety and tolerability of human TH-SC01 cell injection for the treatment of perianal fistulas in Crohn's Disease
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.