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 range
18 Years – 70 Years
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.