Evaluate the Distribution and Dynamic Behavior of TH-SC01 Cells in Vivo in Patients With Perianal Fistula
NCT ID: NCT06429241
Last Updated: 2024-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
8 participants
INTERVENTIONAL
2024-04-08
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MSCs treatment group
Intralesional injection of expanded human umbilical cord-derived mesenchymal stem cells suspension.
Mesenchymal Stem Cells (MSCs)
single dose injection (120 million cells)
Interventions
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Mesenchymal Stem Cells (MSCs)
single dose injection (120 million cells)
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
70 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Soochow University
OTHER
Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The first Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Countries
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Central Contacts
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Miu Li Yan The First Affiliated Hospital of Soochow University
Role: CONTACT
Facility Contacts
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Other Identifiers
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2023-TH-SC01-I-007
Identifier Type: -
Identifier Source: org_study_id
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