Study on the Treatment of Anal Fistulas Using Alofisel Versus Fat Autologous Stem Cells
Observational · No treatment assigned · 1 site · Nantes University Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn Disease and Anal Fistula. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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…
There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 20 participants are expected to take part.
- Start date: 2024-01-02.
- Main results expected around 2025-01-02 (estimate from the record).
- 1 study site listed (1 marked recruiting) in France.
Main thing being measured
- Comparing the efficacy of Alofisel treatment versus fat grafting in Crohn's disease complex perianal fistulae (1 month after the surgery)
In the researchers’ words
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 with stem cells.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn Disease; Anal Fistula |
| Lead sponsor | Nantes University Hospital |
| Enrollment | 20 (estimated) |
| Start date | 2024-01-02 |
| Primary completion (est.) | 2025-01-02 |
| First posted | 2023-08-03 |
| Last updated | 2026-06-24 |
| Official title | Pilot Study on the Treatment of Anal Fistulas in Crohn's Disease Patients Using Alofisel Versus Fat Autologous Stem Cells |
| ClinicalTrials.gov ID | NCT05974280 |
Interventions
- Alofisel (Drug)
Alofisel is made up of 'mesenchymal stem cells' from the fat tissue of a donor. Alofisel is a medicine that is used to treat complex anal fistulas in adults with Crohn's disease - Fat stem cell (Drug)
mesenchymal stem cells from adipose (fat) tissue injection
Full eligibility criteria (from the record)
Inclusion Criteria: * 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 Criteria: * 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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Nantes | Nantes, Nantes | France | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.