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.

Официальное название

Clinical Study on the Integration of Traditional Chinese Medicine Xu Gua Therapy With Mesenchymal Stem Cells for the Treatment of Crohn's Disease-Associated Anal Fistula.

Обзор

To evaluate the efficacy and safety of TCM virtual hanging therapy combined with mesenchymal stem cellsin the treatment of CD anal fistula. To establish the standard of clinical diagnosis and treatment and thestandard procedure of operation for the treatment of CD anal fistula by virtual hanging therapy combinedwith mesenchymal stem cells.

Вмешательства

• Процедура 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.
• Процедура Dummy Line Therapy Group
  Utilizes traditional thread-embedding techniques, placing specialized threads at specific sites to effectively drain inflammatory exudates and necrotic materials.
• Процедура MSC Group
  Administers mesenchymal stem cell injections directly to target areas, leveraging their differentiation and anti-inflammatory properties to enhance tissue repair.

Первичные конечные точки

• CD anal fistula healing rate [Срок оценки: From enrollment to the end of treatment at 24 weeks]

Вторичные конечные точки (10)

• CDAI [Срок оценки: From enrollment to the end of treatment at 24 weeks]
• PDAI [Срок оценки: From enrollment to the end of treatment at 24 weeks]
• IBDQ [Срок оценки: From enrollment to the end of treatment at 24 weeks]
• Van Assche [Срок оценки: From enrollment to the end of treatment at 24 weeks]
• VAS [Срок оценки: From enrollment to the end of treatment at 24 weeks]
• Wexner [Срок оценки: From enrollment to the end of treatment at 24 weeks]
• Erythrocyte Sedimentation Rate (ESR) [Срок оценки: From enrollment to the end of treatment at 24 weeks]
• Fecal Calprotectin [Срок оценки: From enrollment to the end of treatment at 24 weeks]
• C-reactive Protein (CRP) [Срок оценки: From enrollment to the end of treatment at 24 weeks]
• Anorectal Manometry [Срок оценки: From enrollment to the end of treatment at 24 weeks]

Критерии участия

Критерии включения

Signed informed consent form.

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.

Критерии исключения

CDAI >220 or requiring immediate treatment for active CD.

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Nanjing Hospital of Traditional Chinese Medicine (Affiliated Hospital of Nanjing Universit — Нанкин

Идентификаторы

NCT: NCT07113795 · BE2022674

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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