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Fat cells injected into esophagus could tame reflux without surgery

NCT ID NCT07638423

Disease control Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tests whether injecting a patient's own fat-derived cells into the lower esophagus is safe and feasible for treating GERD that doesn't respond well to medication. Fifteen adults with chronic acid reflux will undergo a minimally invasive endoscopic procedure. The goal is to see if this cell therapy can strengthen the anti-reflux barrier and help patients reduce or stop daily acid-reflux pills.

What this could mean

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

Active substance
patient's own fat-derived cells (stromal vascular fraction)
What this could lead to
If it works, this could offer a minimally invasive, cell-based alternative to surgery for GERD, potentially reducing or eliminating the need for daily acid-reflux medication.
What could go wrong
This is a very early, small pilot study with only 15 participants, so results may not apply to everyone. The procedure is new and risks like bleeding, infection, or no improvement are possible.

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 15 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

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.

Ages

18 to 75 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: * Adults 18-75 years; actionable GERD per Lyon 2.0 (e.g., AET \>6% off therapy; or LA grade B-D, peptic stricture, Barrett's) and compatible symptoms. \[2\] * Refractory symptoms on optimized PPIs or PPI-dependent disease where intervention is contemplated. \[2\] * HRM excluding major motility disorders (per Chicago v4.0). \[21\] * Willing to undergo adipose harvest and autologous SVF therapy within a clinical trial framework. Exclusion Criteria: * Hiatal hernia \>3 cm or paraesophageal hernia; severe esophagitis with ulcers (grade B or more); Barrett's with dysplasia; strictures; achalasia/EGJOO/spastic disorders. \[2,21\] * Coagulopathy, uncontrolled cardiopulmonary disease, pregnancy/lactation. * Active infection/malignancy significant for increased risk, at PI discretion. * Prior fundoplication or magnetic sphincter augmentation within 12 months.

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Conditions

The condition(s) this trial relates to.

gastroesophageal reflux disease

As listed by the trial registrant

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

GERD (gastroesophageal reflux disease)

How to take part

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  1. 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 ↗

  2. A doctor treating you

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