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New treatment option for Crohn's Disease
Official title Phase 3 Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease
ClinicalTrials.gov ID: NCT06925594
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 24 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Signed informed consent
- people with Crohn's disease diagnosed at least 6 months earlier according to the Chinese Consensus Opinion on the Diagnosis and Treatment of...
- people 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...
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
You likely can't join if
- people allergic to human serum albumin, human platelet lysate, gentamicin sulfate, anesthetic drugs or MRI contrast agents.
- people with active infection evaluated by the investigator
- people with active Crohn's disease before drug administration or have not completed the induction-phase treatment.
- people with abscess or collections \>2 cm.
- Rectal and/or anal stenosis , if this means a limitation for any surgical procedure
- people with concurrent active proctitis.
See the full eligibility criteria
- Signed informed consent
- people 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)
- people 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.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- American Society of Anesthesiologists (ASA) physical status classification of grade I to grade II.
- All people 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.
- people allergic to human serum albumin, human platelet lysate, gentamicin sulfate, anesthetic drugs or MRI contrast agents.
- people with active infection evaluated by the investigator
- people with active Crohn's disease before drug administration or have not completed the induction-phase treatment.
- people with abscess or collections \>2 cm.
- Rectal and/or anal stenosis , if this means a limitation for any surgical procedure
- people with concurrent active proctitis.
- people with other fistulas such as rectum/anal canal-vaginal fistulas or rectum-bladder fistulas.
- Patients have undergone a diverting stoma operation in the past, except for patients have completed stoma closure at least one month before drug administration.
- Patients plan to undergo surgery in the perianal area during the trial period due to other diseases other than anal fistula.
- people 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...
- Serum virology test (HBeAg, HCV antibody, HIV antibody, Treponema pallidum antibody) positive.
- people with malignant tumors or a history of malignant tumors.
- people with congenital or acquired immunodeficiency.
- Contraindication to MRI scan
- Current or recent history of abnormal, severe, progressive, uncontrolled hepatic, haematological, gastrointestinal (except CD), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral disease.
- people received stem cell treatment within two years prior to screening.
- Patient with ongoing steroid treatment or treated with steroids in the last 4 weeks.
- Patient undergone major surgical operations (such as orthopedic surgery, abdominal surgery) within one month before drug administration, or Patient plan to receive surgeries during the study period (except for the...
- Patients with a history of drug abuse or alcoholism (Criteria for alcoholism: having a long-term drinking history of more than 5 years, with the amount of ethanol equivalent to ≥40g/d for men and ≥20g/d for women, or...
- Pregnant or lactating women.
- Patients with a history of diverting ostomy, except those who have undergone stoma reversal at least 1 month prior to drug administration.
- Other diseases or conditions that the investigator deems inappropriate for participating in this clinical trial, such as poor subject compliance and the expectation of being unable to complete follow-up and evaluation.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.