NCT07113795Enrolling By Invitation1 期
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.
The Anorectal Center of Nanjing Hospital of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年7月1日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- CD anal fistula healing rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
CD anal fistula healing rate
时间窗: From enrollment to the end of treatment at 24 weeks
Post-treatment healing rate of Crohn's disease-related anal fistula, defined as clinical closure of all external fistula openings in patients, combined with MRI-confirmed fistula tract healing.
次要结局
- CDAI(From enrollment to the end of treatment at 24 weeks)
- PDAI(From enrollment to the end of treatment at 24 weeks)
- IBDQ(From enrollment to the end of treatment at 24 weeks)
- Van Assche(From enrollment to the end of treatment at 24 weeks)
- VAS(From enrollment to the end of treatment at 24 weeks)
- Wexner(From enrollment to the end of treatment at 24 weeks)
- Erythrocyte Sedimentation Rate (ESR)(From enrollment to the end of treatment at 24 weeks)
- Fecal Calprotectin(From enrollment to the end of treatment at 24 weeks)
- C-reactive Protein (CRP)(From enrollment to the end of treatment at 24 weeks)
- Anorectal Manometry(From enrollment to the end of treatment at 24 weeks)
研究者
研究点 (1)
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