Status:
RECRUITING
Study on the Treatment of Anal Fistulas Using Alofisel Versus Fat Autologous Stem Cells
Lead Sponsor:
Nantes University Hospital
Conditions:
Crohn Disease
Anal Fistula
Eligibility:
All Genders
18+ years
Brief Summary
One of the newest and most innovative medicinal approaches is cell therapy. Several clinical trials and experimental investigations have looked into the feasibility of treating CD-related fistulas wit...
Detailed Description
The trial will be made available to patients who are scheduled for perianal surgery with ALOFISEL® or backup (fat injection). The history and signs of perianal fistula will be noted if the patient doe...
Eligibility Criteria
Inclusion
- Complex anal fistula with the following criteria: - Inactive/slightly active luminal Crohn's disease under conventional treatment or biotherapy MRI has demonstrated effective drainage. Maximum of two internal orifices and three external orifices; persists despite internal orifice(s) closing.
Exclusion
- Pregnant or breast-feeding women
- Patients hypersensitive to the product, bovine serum or any of the excipients of Alofisel
- Vulnerable persons: deprived of liberty, under guardianship, under curatorship, etc.
Key Trial Info
Start Date :
January 2 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05974280
Start Date
January 2 2024
End Date
June 1 2025
Last Update
December 27 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU Nantes
Nantes, France, 44000