Clinical Study on the Integration of Traditional Chinese Medicine Virtual Hanging Therapy With Me… (NCT07113795) | Clinical Trial Compass
By InvitationEarly Phase 1
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.
China90 participantsStarted 2022-07-01
Plain-language summary
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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion Criteria:
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 Criteria:
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).
Curren…
What they're measuring
1
CD anal fistula healing rate
Timeframe: From enrollment to the end of treatment at 24 weeks
Trial details
NCT IDNCT07113795
SponsorThe Anorectal Center of Nanjing Hospital of Traditional Chinese Medicine