Efficacy of Cx601 (Darvadstrocel) for the Treatment of Perianal Fistulizing Crohn's Disease
NCT ID: NCT05322057
Last Updated: 2022-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
14 participants
OBSERVATIONAL
2018-10-01
2021-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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patients with Crohn's disease and complex perianal fistula
14 patients with Crohn's disease refractory to standard treatment for complex perianal fistula got enrolled in this study.
Darvadstrocel
Injection of 120 million allogeneic expanded adipose-derived mesenchymal stem cells around the fistula opening and around the fistula tract
Interventions
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Darvadstrocel
Injection of 120 million allogeneic expanded adipose-derived mesenchymal stem cells around the fistula opening and around the fistula tract
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* rectal and/or anal stenosis
* active proctitis
* diverting stomas
* an abscess (\<2cm) that was not drained at the fistula preperation visit
18 Years
90 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Dr. Christopher Dawoud
Dr. med. univ.
Principal Investigators
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Stefan Riss, Prof.MD
Role: STUDY_CHAIR
Medical University of Vienna, Head of Pelvic Floor Surgery
Locations
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Medical University of Vienna
Vienna, , Austria
Countries
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Other Identifiers
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1682/2018
Identifier Type: -
Identifier Source: org_study_id
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