A Study of TH-SC01 for Treating Complex Perianal Fistula in Perianal Crohn's Disease.

• Status: Enrolling by invitation
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to asses the efficacy and Safety of Allogeneic Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Complex Perianal Fistula in Perianal Crohn's Disease.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jinling Hospital, China
• Collaborator: Jiangsu Topcel-KH Pharmaceutical Co., Ltd

Criteria

Inclusion Criteria:

• 1. Signed Informed Consent；

• 2. According to the Diagnostic Criterion for Crohn's Disease in China's 《Consensus on the Diagnosis and Treatment of Inflammatory Bowel Disease》 (2018, Beijing), Crohn's disease was diagnosed at least 6 months before the screening period；

• 3. Crohn's disease activity index (CDAI) score of 220 or less is defined as inactive or mildly active luminal Crohn's disease；

• 4. Through clinical evaluation, MRI evaluation for anal fistula patients；

• 5. Age 18 ~ 70, male or female；

• 6. The serum or urine pregnancy test of a woman of reproductive age must be negative. Both men and women must agree to use a contraceptive method；

• 7. According to the history and related examination, the general health condition is good；

• 8. The eligible patients must at least meet one of the following conditions: patients who have failed to respond to any conventional treatment, such as conventional antibiotic therapy, immunomodulatory drug therapy, anti-tumor necrosis factor (TNF) α monoclonal antibody therapy, and 5-aminosalicylic acid

Exclusion Criteria:

• 1. CDAI > 220, or due to Crohn's disease activity, treatment needs to be upgraded immediately；

• 2. Patients with abdominal and pelvic abscess or fistula diameter more than 2 cm；

• 3. Patients with rectal and/or anal stenosis and/or active proctitis (due to limited surgical procedures)；

• 4. The number of internal and / or external openings of anal fistula was more than 2 and 3 respectively;

• 5. Patients who received steroid therapy within the first 4 weeks were screened；

• 6. Abnormal laboratory test results： Liver function: total bilirubin ≥1.5 times the upper limit of normal value, aspartate aminotransferase (AST) or alanine aminotransferase (ALT)≥2.5 times the upper limit of normal value; Renal function: Creatinine clearance below 60mL/min or 1.5 times the upper normal limit of serum creatinine (measured value or calculated by the Cockcroft-Gault formula)；

• 7.Patients with malignancy or a history of malignancy, including fistula cancer of any type；

• 8. Patients with severe, progressive, uncontrollable diseases of the liver, blood, gastrointestinal (except Crohn's disease), endocrine, lung, heart, neurological, psychiatric, or brain；

• 9. HIV, syphilis antibody positive, HCV / HBV positive, tuberculosis in the infectious period, etc;

• 10. Patients who are allergic to human serum albumin, human platelet lysates, anesthetic agents or contrast agents；

• 11. Patients with contraindications to MRI scanning；

• 12. Pregnant or lactating women and subjects who cannot commit to using effective contraceptives during the trial and for 6 months after the end of the trial；

• 13. Patients who have undergone major surgery or severe trauma in the past six months；

• 14. Patients who had received any study drug within a certain period of time prior to screening；

• 15.Patients deemed ineligible to participate in this clinical trial by the investigator