Evaluate the Distribution and Dynamic Behavior of TH-SC01 Cells in Vivo in Patients With Perianal Fistula

Launched by JIANGSU TOPCEL-KH PHARMACEUTICAL CO., LTD. · May 20, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new type of cell therapy for patients with perianal fistulas, which are abnormal connections that can occur around the anus, often related to Crohn's disease. The goal of the study is to understand how these specially labeled cells, called TH-SC01, behave in the body and where they go after being given to patients. Researchers hope this information will help improve treatment for people suffering from these complex conditions.

To be eligible for the trial, participants need to be adults diagnosed with Crohn's disease or a complex perianal fistula for at least six months and have not responded to standard treatments. Participants should not have any active infections or serious health issues, and they need to agree to use effective contraception during the study. Those who join the trial will receive the TH-SC01 cells and will be monitored to see how the cells move and act in their bodies. This study is currently recruiting, so interested patients can reach out to find out more about participation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed informed consent
• • 2. Subjects with Crohn\'s disease or complex perianal fistula 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.
• • 3. For patients with perianal fistula, 1≤ the number of internal openings ≤2, and 1≤ the number of external openings ≤3, the fistula of the patient needs to be drained smoothly
• • 4. 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.
• • 5. ECOG score 0\~1, ASA grade I\~II
• • 6. 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:
• • 1. Subjects with active infection evaluated by the investigator.
• • 2. Subjects with Crohn\'s disease requiring immediate therapy.
• • 3. Subjects with abscess or collections \>2 cm.
• • 4. Subjects with rectal and/or anal stenosis and/or active proctitis.
• • 5. Subjects who treated with systemic steroids in the 4 weeks prior to stem cells administration.
• • 6. 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).
• • 7. Subjects with malignant tumors or a history of malignant tumors.
• • 8. Subjects with severe, progressive, uncontrolled hepatic, hematological, gastrointestinal (except Crohn\'s disease), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral diseases.
• • 9. Serum virology test (HBeAg, HCV antibody, HIV antibody, Treponema pallidum antibody) positive.
• • 10. Subjects allergic to Human serum albumin, human platelet lysate, gentamicin sulfate, anesthetic drug
• • 11. Subjects who has received stem cells therapy.
• • 12. Subjects who has major surgery or severe trauma within 6 months prior to the screening period.
• • 13. Subjects who has received any investigational drug within 3 months prior to the screening.
• • 14. Subjects deemed inappropriate by the investigator to participate in this clinical trial.
• • 15. The female participant who is pregnant, or is lactating.
• • 16. Not suitable for PET/CT examination.
• • 17. Participants considered inappropriate to participate in this clinical trial