Evaluating TH-SC01 Cells in Patients with Perianal Fistula

A Phase I Clinical Study Evaluating the Distribution and Dynamic Behavior of Nuclide Labeled TH-SC01 Cells in Vivo in Patients With Perianal Fistula

This study is testing how a new type of stem cell treatment works in people with perianal fistulas who haven't found relief from regular treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Jiangsu Topcel-KH Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT06429241 on ClinicalTrials.gov

What this trial studies

This Phase I clinical study aims to assess how Nuclide labeled TH-SC01 cells behave and distribute within the body of patients suffering from perianal fistula. The study will involve patients diagnosed with Crohn's disease or complex perianal fistulas, focusing on those who have not responded to conventional treatments. Participants will receive mesenchymal stem cells (MSCs) as an intervention, and their responses will be monitored to gather data on the cells' dynamics in vivo.

Who should consider this trial

Good fit: Ideal candidates include individuals with Crohn's disease or complex perianal fistulas who have not responded to standard treatments and meet specific inclusion criteria.

Not a fit: Patients with perianal fistulas that do not meet the study's inclusion criteria or those who have not been diagnosed with Crohn's disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel treatment option for patients with complex perianal fistulas, potentially improving healing and quality of life.

How similar studies have performed: While this approach is novel, similar studies involving stem cell therapies for inflammatory conditions have shown promise, suggesting potential for success.

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

Where this trial is running

Suzhou, Jiangsu

• The first Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Miu Li Yan The First Affiliated Hospital of Soochow University

Conditions Anal Fistula; Complex Perianal Fistulas; Crohn's Disease