Clinical Study on the Integration of Traditional Chinese Medicine Virtual Hanging Therapy With Mesenchymal Stem Cells for the Treatment of Crohn's Disease-Associated Anal Fistula.
NCT ID: NCT07113795
Last Updated: 2025-08-11
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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ENROLLING_BY_INVITATION
EARLY_PHASE1
90 participants
INTERVENTIONAL
2022-07-01
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Association Group
receiving a combination of TCM dummy therapy and mesenchymal stem cell injection therapy
TCM dummy therapy combined with mesenchymal stem cell injection therapy
Combines TCM dummy therapy with mesenchymal stem cell injection, integrating traditional local stimulation and modern stem cell regenerative mechanisms.
Dummy Line Therapy Group
treated solely with dummy line therapy
Dummy Line Therapy Group
Utilizes traditional thread-embedding techniques, placing specialized threads at specific sites to effectively drain inflammatory exudates and necrotic materials.
MSC Group
administered only mesenchymal stem cell injection therapy
MSC Group
Administers mesenchymal stem cell injections directly to target areas, leveraging their differentiation and anti-inflammatory properties to enhance tissue repair.
Interventions
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TCM dummy therapy combined with mesenchymal stem cell injection therapy
Combines TCM dummy therapy with mesenchymal stem cell injection, integrating traditional local stimulation and modern stem cell regenerative mechanisms.
Dummy Line Therapy Group
Utilizes traditional thread-embedding techniques, placing specialized threads at specific sites to effectively drain inflammatory exudates and necrotic materials.
MSC Group
Administers mesenchymal stem cell injections directly to target areas, leveraging their differentiation and anti-inflammatory properties to enhance tissue repair.
Eligibility Criteria
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Inclusion Criteria
Diagnosis of Crohn's disease (CD) confirmed at least 6 months prior to screening, based on the Chinese Consensus on Diagnosis and Treatment of Inflammatory Bowel Disease (2018, Beijing).
Crohn's Disease Activity Index (CDAI) score ≤220, indicating inactive or mildly active CD.
Presence of complex anal fistula confirmed by clinical and MRI evaluation.
Age 18-60 years (inclusive), regardless of sex.
Negative serum/urine pregnancy test for women of childbearing potential; all participants must agree to use effective contraception during and for 6 months after the trial.
Good general health status confirmed by medical history and relevant examinations.
Exclusion Criteria
Patients with rectal/anal stenosis or active proctitis (due to procedural limitations).
Presence of abscess \>2 cm unless treated ≥2 weeks prior to the trial.
History of fistula surgery (except drainage or seton placement), concurrent need for perianal surgery unrelated to fistula, or anticipated need for such surgery within 24 weeks post-treatment.
Systemic steroid therapy within 4 weeks prior to screening.
Abnormal laboratory results:
Liver function: Total bilirubin ≥1.5×ULN; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5×ULN.
Renal function: Creatinine clearance \<60 mL/min or serum creatinine ≥1.5×ULN (measured or calculated by Cockcroft-Gault formula).
Current or history of malignancy (including fistula-related carcinoma).
Severe, progressive, or uncontrolled hepatic, hematologic, gastrointestinal (excluding CD), endocrine, pulmonary, cardiac, neurologic, psychiatric, or cerebral diseases.
HIV/syphilis antibody positivity, active HCV/HBV infection, or active tuberculosis.
Known allergy to antibiotics or trial-related agents (e.g., penicillin, streptomycin, gentamicin, aminoglycosides, human serum albumin, human platelet lysate, DMEM cell culture medium, or bovine-derived materials).
Intolerance to anesthesia or contraindications to MRI scanning (e.g., pacemaker, hip prosthesis, severe claustrophobia, gadolinium allergy).
Pregnancy, lactation, or refusal to use effective contraception during and for 6 months post-trial.
Major surgery or severe trauma within the past 6 months.
History of alcohol/drug abuse within 6 months prior to enrollment.
Use of investigational drugs within 12 weeks (84 days) prior to screening.
Inability to comply with the study protocol or other conditions deemed unsuitable by investigators.
18 Years
60 Years
ALL
No
Sponsors
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The Anorectal Center of Nanjing Hospital of Traditional Chinese Medicine
NETWORK
Responsible Party
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Locations
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Nanjing Hospital of Traditional Chinese Medicine (Affiliated Hospital of Nanjing University of Chinese Medicine)
Nanjing, Jiangsu, China
Countries
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Other Identifiers
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BE2022674
Identifier Type: -
Identifier Source: org_study_id
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