CompletedNot Applicable

Efficacy of Cx601 (Darvadstrocel) for the Treatment of Perianal Fistulizing Crohn's Disease

Austria14 participantsStarted 2018-10-01

Plain-language summary

The use of mesenchymal stem cells is considered a novel and promising therapeutic option for patients with perianal fistulizing Crohn's disease. However, due to limited clinical data, this multicentre, nationwide study aimed to assess its clinical efficacy in closing complex anal fistula.

Who can participate

Age range18 Years – 90 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * patients aged 18 and older who had a non-active or mildly active luminal CD with complex fistula with a maximum of two internal and three external fistulas Exclusion Criteria: * rectovaginal fistulas * rectal and/or anal stenosis * active proctitis * diverting stomas * an abscess (\<2cm) that was not drained at the fistula preperation visit

What they're measuring

Fistula Closure

Timeframe: 1 year

Trial details

NCT IDNCT05322057

SponsorMedical University of Vienna

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-12-01

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