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Stem cell shot aims to seal Crohn's fistulas

NCT ID NCT06636032

Disease control Sponsor: University Hospital, Toulouse 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early study tests whether injecting stem cells from donated fat tissue can help heal complex anal fistulas in people with Crohn's disease who haven't gotten better with standard treatments. Nine adults will receive the stem cell injection and be followed for six months to check for side effects and signs of healing. The goal is to see if this approach is safe and worth testing in larger studies.

What this could mean

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

Active substance
allogeneic adipose-derived mesenchymal stem cells (AdMSC)
What this could lead to
If it works, this could offer a new way to heal hard-to-treat anal fistulas in Crohn's disease without surgery or strong drugs.
What could go wrong
This is a very small, early-phase trial with only 9 people. It mainly checks safety, not effectiveness. The treatment may not work or could cause side effects.

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.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 9 people

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

Started

Mar 2025

Expected to finish

Sep 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.

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: * Patients over 18 years old, * Patients who signed the informed consent, * Patient affiliated to a social security system, * Controlled luminal Crohn's disease characterized by an Harvey-Bradshaw score less or equal than 8 and diagnosed on clinical, endoscopic, histological and/or radiological criteria for more than 3 months, * Colonoscopy less than a year old without ulcer in the rectum, * Presence of complex chronic perianal fistula with a maximum of two internal ports and three external ports, * Patient treated with a combined treatment (drainage on setons + anti-TNFα) and who failed conventional treatment after 6 months and whose intraluminal disease (intestinal damage) is controlled Exclusion Criteria: * Refusal of the patient to participate in the study, * Positive QuantiFERON test, * Patient with transplanted organ, * History of cancer in the last five years or lympho-proliferative disease, * Persistent bacterial or viral infection, * Patient with a contraindication to MRI, * Known allergy to Gadolinium, * Known allergy to Albumine, * End-stage organ failure, * Pregnant or breastfeeding women, * Women of childbearing age without effective contraception throughout the duration of the study, * Patient under judicial protection, under guardianship or curatorship. * Patient previously treated with ALOFISEL®

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

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

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

  • Toulouse Hospital

    RECRUITING

    Toulouse, France

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