Status:
COMPLETED
Treatment of Complex Anal Fistulas Using Centrifuged Adipose Tissue Containing Progenitor Cells
Lead Sponsor:
University Hospital of Ferrara
Conditions:
Anal Fistula
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In the treatment of complex anal fistulas transplant of freshly collected autologous adipose tissue mechanically fragmented or centrifuged adipose tissue (CAT) might be an alternative to in vitro expa...
Detailed Description
This monocentric randomized controlled study was designed to test the efficacy and safety of injection of CAT for treatment of complex fistula-in ano, not associated with CD . The study was conducted ...
Eligibility Criteria
Inclusion
- Patients aged 18 years or older with complex perianal fistulas
Exclusion
- Inflammatory bowel diseases, Crohn's Disease (CD) or Ulcerative Colitis (UC) Hepatitis B or C virus Infection with Human immunodeficiency virus Surgery for a malignant tumor during the previous 5 years (excluding in situ carcinoma) Previous pelvic radiotherapy Autoimmune disease Active tuberculosis Symptoms of septicemia Breastfeeding or pregnant women Women unwilling to use contraception during the study Psychiatric disorders Alcoholism Drug dependency Allergy to local anesthetics
Key Trial Info
Start Date :
May 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04326907
Start Date
May 1 2016
End Date
October 1 2019
Last Update
March 30 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Simona Ascanelli
Ferrara, Italy, 44121