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Stem cell showdown: donor vs. your own fat for Crohn's fistulas

NCT ID NCT05974280

Disease control Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tests two stem cell treatments for anal fistulas in people with Crohn's disease. One uses donor stem cells (Alofisel), the other uses stem cells from the patient's own fat. The goal is to see which works better at closing the fistula. The study plans to enroll 20 adults with complex anal fistulas.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
stem cells (Alofisel or fat-derived stem cells)
What this could lead to
If successful, this could point toward a more affordable and effective treatment for anal fistulas in Crohn's disease, potentially using the patient's own fat cells.
What could go wrong
This is a very small pilot study with only 20 participants, so results may not apply to everyone. The high cost and complexity of Alofisel may limit its use, and the autologous fat approach is still experimental.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Population with Crohn's disease coming to the digestive surgery department of the CHU in Nantes for perianal surgery

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

anal fistula Crohn disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anal fistula Crohn disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Nantes

    RECRUITING

    Nantes, Nantes, 44000, France

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