Status:
COMPLETED
Efficacy of Cx601 (Darvadstrocel) for the Treatment of Perianal Fistulizing Crohn's Disease
Lead Sponsor:
Medical University of Vienna
Conditions:
Crohn Disease
Fistula Perianal
Eligibility:
All Genders
18-90 years
Brief 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...
Detailed Description
Fifteen applications in 14 patients (3 male, 11 female) with complex anal fistulas treated in three tertiary hospitals in Austria were included between October 2018 and April 2021. Injection of 120 mi...
Eligibility Criteria
Inclusion
- 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
- rectovaginal fistulas
- rectal and/or anal stenosis
- active proctitis
- diverting stomas
- an abscess (\<2cm) that was not drained at the fistula preperation visit
Key Trial Info
Start Date :
October 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT05322057
Start Date
October 1 2018
End Date
December 1 2021
Last Update
April 11 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical University of Vienna
Vienna, Austria, 1090