Status:
COMPLETED
Stem Cells Treatment of Complex Crohn's Anal Fistula
Lead Sponsor:
University of Southern Denmark
Collaborating Sponsors:
Odense University Hospital
Conditions:
Anal Fistula
Crohn Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A pilot study to investigate the safety and feasibility of stem cells treatment of complex anal fistula in patients with Crohn's disease.
Detailed Description
Stem cells therapy in the management of soft tissue healing has been shown to be safe and feasible with encouraging short-term results both for crypto glandular and Crohns anal fistula. The long-term ...
Eligibility Criteria
Inclusion
- patients with Crohn's anal fistulas and\> 18 yrs old.
Exclusion
- Signs of suppuration around the fistula
- Active intestinal Crohn disease not in remission
- Malignancy within 5 years
- Previous radiotherapy of the abdomen and pelvis
- BMI under 18.5
- Coagulopathy
- Fistula with side branches
- Low anal fistula
- Verified syphilis, HIV, or hepatitis on screening test.
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03466515
Start Date
June 1 2018
End Date
December 31 2020
Last Update
February 1 2021
Active Locations (1)
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1
Odense University Hospital
Odense, Denmark, 5000