Status:
COMPLETED
National Project to Implement Mesenchymal Stem Cell for the Treatment of Perianal Crohn's Fistula (the PRIME Study)
Lead Sponsor:
Universidad de Zaragoza
Collaborating Sponsors:
Hospital Universitario Fundación Jiménez Díaz
Conditions:
Safety
Efficacy, Self
Eligibility:
All Genders
18+ years
Brief Summary
Darvadstrocel is an expanded allogeneic adipose-derived mesenchymal stem cell therapy for the treatment of complex perianal fistulas in patients with Crohn's disease. Safety and efficacy of the proced...
Eligibility Criteria
Inclusion
- Adults aged 18 years or older who have complex perianal Crohn fistula
- non-active or mildly active luminal Crohn's disease for at least 6 months.
- The fistula had to have been draining for at least 6 weeks before inclusion.
Exclusion
- • Patient with recto-vaginal fistula; rectal or anal stenosis; or active severe proctitis.
Key Trial Info
Start Date :
January 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2022
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT05210309
Start Date
January 1 2020
End Date
April 30 2022
Last Update
January 18 2023
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital de Elche
Elche, Alicante, Spain
2
HOSPITAL Meixoeiro Vigo
Vigo, Pontevedra, Spain
3
Hospital Vall D´Hebron
Barcelona, Spain
4
Hospital La Fe
Valencia, Spain