Clinical trial NCT06429241: Evaluate the Distribution and Dynamic Behavior of TH-SC01 Cells in Vivo in Patients With Perianal Fistula
Official title: A Phase I Clinical Study Evaluating the Distribution and Dynamic Behavior of Nuclide Labeled TH-SC01 Cells in Vivo in Patients With Perianal Fistula
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Anal Fistula
Complex Perianal Fistulas
Crohn's Disease
Lead sponsor: Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: The First Affiliated Hospital of Soochow University
First posted: 2024-05-24
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with perianal fistula

Detailed description: A Phase I clinical study evaluating the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with perianal fistula

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent
2. Subjects with Crohn\&amp;#39;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\&amp;amp;amp;#39;s disease requiring immediate therapy.
3. Subjects with abscess or collections \&amp;amp;amp;gt;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 \&amp;amp;amp;gt;=1.5 × ULN, and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \&amp;amp;amp;gt;=2 × ULN; renal function: creatinine clearance below 60 mL/minute calculated using Cockcroft-Gault formula or by serum creatinine \&amp;amp;amp;gt;=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\&amp;amp;amp;#39;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

Primary outcomes:
measure: Standardized uptake value
timeFrame: 8-12 hour、32-36 hour、56-60 hour、104-108 hour、152-156 hour，296-300 hour
Secondary outcomes:
measure: Effectiveness endpoint:Proportion of subjects with clinically significant effect at week 24 after local injection
timeFrame: Week 1，Week 4，Week 24
measure: Safety endpoint: Treatment-related adverse events/adverse reactions, serious adverse events/serious adverse events
timeFrame: Week 1，Week 4，Week 24，Month 24
measure: Radiation exposure: Uptake rate (%ID), absorbed dose, and systemic effective dose in vital organs or tissues after local injection of nuclide labeled TH-SC01 cells.
timeFrame: Week 1
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The first Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
References: