Recruiting
CHAZAMPilot Study on the Treatment of Anal Fistulas in Crohn's Disease Patients Using Alofisel Versus Fat Autologous Stem Cells
What is being collected
Data Collection
Collected from today forward - ProspectiveWho is being recruted
Crohn Disease+10
+ Digestive System Diseases
+ Fistula
Over 18 Years
+4 Eligibility Criteria
How is the trial designed
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Observational
Study Start: January 2024
Summary
Principal SponsorNantes University Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: January 2, 2024
Actual date on which the first participant was enrolled.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 doesn't object. Two visits that correspond to typical follow-up visits for patients will be noted: Visit following surgery: fistula clinical evaluation, analgesic use, etc. and six months after : clinical assessment, MRI
Official TitlePilot Study on the Treatment of Anal Fistulas in Crohn's Disease Patients Using Alofisel Versus Fat Autologous Stem Cells
Principal SponsorNantes University Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Crohn DiseaseDigestive System DiseasesFistulaGastroenteritisGastrointestinal DiseasesIntestinal DiseasesIntestinal FistulaRectal DiseasesRectal FistulaPathological Conditions, Signs and SymptomsInflammatory Bowel DiseasesDigestive System FistulaPathological Conditions, Anatomical
Criteria
1 inclusion criteria required to participate
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.
3 exclusion criteria prevent from participating
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Recruiting
Recruiting
One Study Center