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Fat cell therapy shows promise for Hard-to-Heal gut holes

NCT ID NCT07661043

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 trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study looks at whether injecting a patient's own fat-derived cells can help close abnormal connections (fistulas) in the gut that won't heal with standard treatments. Researchers will track 50 adults to see what factors predict successful closure. The goal is to understand who benefits most from this regenerative approach.

What this could mean

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

Active substance
fat-derived regenerative cells (stromal vascular fraction)
What this could lead to
If successful, this could identify which patients and techniques lead to fistula healing, guiding better use of this regenerative therapy.
What could go wrong
This is a small, early observational study (50 patients) with no control group. It only looks for factors linked to success, not proving the therapy works. Fistulas may not heal or could recur.

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.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Aug 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: * Age ≥18 years * Confirmed benign gastrointestinal fistula involving the luminal gastrointestinal tract * Fistula accessible for endoscopic evaluation and treatment * Planned treatment with endoscopic tSVF-EM therapy, with or without adjunctive endoscopic therapies (argon plasma coagulation \[APC\], tract abrasion/curettage, clips, over-the-scope clips \[OTSC\], endoscopic suturing, or stent placement) * Ability and willingness to provide written informed consent * Willingness to comply with scheduled follow-up visits and study assessments Exclusion Criteria: * Perianal fistulas of any aetiology * Inflammatory bowel disease-associated fistulas, including fistulas related to Crohn's disease or ulcerative colitis * Malignancy-related fistulas * Fistulas requiring primary oncologic surgical management * Uncontrolled sepsis or undrained abscess at baseline (patients may become eligible following adequate drainage and clinical stabilisation) * Contraindication to adipose tissue harvest, sedation, anaesthesia, or therapeutic endoscopy * Pregnancy or lactation * Severe coagulopathy not correctable prior to intervention * Inability to provide informed consent * Anticipated inability to complete study follow-up * Participation in another interventional study that may influence fistula healing outcomes

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Conditions

The condition(s) this trial relates to.

Digestive System Fistula Fistula intestinal fistula

As listed by the trial registrant

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

Fistula Regenerative medicine Stromal vascular fraction

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

  • AIG Hospitals

    Hyderabad, Telangana, 500075, India

More trials for these conditions

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