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Could your own belly fat fix a stubborn Crohn's fistula?

NCT ID NCT07652632

Disease control Sponsor: Asian Institute of Gastroenterology, India 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new procedure for people with Crohn's disease who have anal fistulas that haven't healed with standard treatments. Doctors take a small amount of fat from the patient's belly, process it mechanically in the same surgery, and inject it into the fistula tract. The goal is to see if this approach is feasible and safe, and whether it might help the fistula heal. The study will enroll 50 adults in India.

What this could mean

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

Active substance
Autologous mechanical tissue stromal vascular fraction (tSVF) injection
What this could lead to
If this works, it could offer a new, simpler way to heal stubborn anal fistulas in Crohn's disease without complex lab processing.
What could go wrong
This is a very early, small pilot study with no control group. It only tests if the procedure is feasible and safe, not if it truly works better than existing treatments.

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 50 people

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

Started

Apr 2026

Expected to finish

Mar 2028

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 to 65 years

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: * Age 18-65 years * Crohn's disease with complex perianal fistula (≥1 secondary tract or internal opening involvement) * Refractory to ≥1 biologic and/or ≥1 prior sphincter sparing procedure * No abscess on screening MRI * Mild or no proctitis on endoscopic assessment * CDAI \<220 * Stable IBD therapy ≥8 weeks * Able to provide informed consent Exclusion Criteria: * Rectovaginal fistula * Severe active proctitis requiring urgent escalation * Malignancy in tract or pelvic region * Pregnancy or lactation * ASA IV status or bleeding disorder * MRI contraindications

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Conditions

The condition(s) this trial relates to.

Crohn disease perianal Crohn disease

As listed by the trial registrant

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

Crohn disease (CD) Perianal crohns disease

How to take part

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

  1. The places running it

    2 sites. 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

  • AIG Hospitals

    RECRUITING

    Hyderabad, Telangana, 500032, India

  • AIG Hospitals

    RECRUITING

    Hyderabad, Telangana, 500032, India

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