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Could your own fat heal Crohn's fistulas and prevent a colostomy bag?

NCT ID NCT05594862

Disease control Sponsor: Lipogems International spa Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether injecting a person's own processed fat tissue can heal complex anal fistulas caused by Crohn's disease that have not responded to standard treatments. About 80 adults with Crohn's and active fistulas will receive either the fat injection plus standard care or standard care alone. The main goal is to see if the fistulas close completely by 24 weeks, which could improve quality of life and reduce the need for a permanent colostomy.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

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

Started

Jan 2023

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * The patient's age is over 18 at the time of surgery. * The patient suffers from Crohn's disease confirmed by instrumental and histological methods. * The patient presents with complex perianal fistulising disease refractory to standard treatment (combination of surgical drainage of sepsis and local / systemic administration of anti-TNF-α for at least 1 year) * The patient received, understood and signed informed consent for active participation in the study. * The patient is able to understand the conditions of the study and to participate throughout the duration. Exclusion Criteria: * Patients with more than 1 internal and 3 external openings. * Patients with ileus / colo ostomy. * Patients with anus / rectum-vaginal fistulas. * Patients with active HIV infections, hepatitis C (HCV), hepatitis B (HBV), tuberculosis. * Patients with abdominal localization of Crohn's disease who may require general surgery during the study. * Patients with active oncological or lymphoproliferative diseases from which it was not possible to safely withdraw an adequate quantity of lipoaspirate (at least 60 cc). * Patients with clinical conditions that may compromise the success of the surgery or the follow-up. * Pregnant or breastfeeding women.

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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

Contacts and locations

Locations

  • IRCCS S Orsola Malpighi

    Bologna, Bologna, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.