Tests traditional Chinese therapy with stem cells for Crohn's fistulas
Tests a traditional Chinese therapy with stem cells in adults with Crohn's anal fistula.
Plain-language title generated from the registry record
Registry title: 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.
Key facts
- Where
- Nanjing, ChinaSee the site
- Phase
- Early phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT07113795, who can take part
Where in China
- Nanjing Hospital of Traditional Chinese Medicine (Affiliated Hospital of Nanjing University of Chinese Medicine)Nanjing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Anorectal Center of Nanjing Hospital of Traditional Chinese Medicine
- Trial code
- NCT07113795
- Record updated
- 11 August 2025
- Original description
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.Read full original descriptionShow less
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.
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.
Inclusion: 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.
Exclusion: 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; 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; 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; Intolerance to anesthesia or contraindications to MRI scanning (e.g., pacemaker, hip prosthesis, severe claustrophobia, gadolinium allergy); Inability to comply with the study protocol or other conditions deemed unsuitable by investigators; 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); 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); CDAI >220 or requiring immediate treatment for active CD; Patients with rectal/anal stenosis or active proctitis (due to procedural limitations); Pregnancy, lactation, or refusal to use effective contraception during and for 6 months post-trial.