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Amniotic cell secretions may fight gut inflammation and scarring — a lab study puts them to the test

NCT ID NCT07721207

Knowledge-focused Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This lab study tests whether a cell-free mixture of molecules and particles released by human amniotic mesenchymal stromal cells can reduce inflammation, prevent scarring, and promote healing in gut tissue from people with inflammatory bowel disease (Crohn's disease or ulcerative colitis). Researchers will expose tissue samples and immune cells from 40 patients to the secretome and measure changes in immune cells, inflammatory signals, and fibrosis markers. The goal is to see if this approach could one day lead to a new treatment for patients who do not respond well to current therapies.

What this could mean

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

Active substance
a cell-free mixture of molecules and particles released by human amniotic mesenchymal stromal cells
What this could lead to
If the secretome reduces inflammation and fibrosis in lab samples, it could point toward a new treatment for hard-to-treat inflammatory bowel disease.
What could go wrong
This is an early lab study using tissue samples, not a treatment given to people. Even promising lab results may not translate into a safe or effective therapy.

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 40 people

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

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Dec 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 diagnosis of inflammatory bowel disease (IBD), including Crohn's disease or ulcerative colitis * Classification into one of the predefined clinical subgroups (remission, active treatment-naïve disease, refractory disease defined as failure of ≥2 lines of therapy, or fibrostenotic Crohn's disease phenotype) * Availability of intestinal biopsies and/or peripheral blood mononuclear cells (PBMCs) for ex vivo analyses * Written informed consent for collection, storage, and use of biological samples for research purposes, in accordance with the Declaration of Helsinki and local Ethics Committee approval Exclusion Criteria: * Age \< 18 years * Presence of systemic diseases not related to inflammatory bowel disease (IBD) that may interfere with immunological or molecular analyses * Inadequate or unavailable biological material for ex vivo experiments, including inability to generate patient-derived intestinal organoids

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

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

Inflammatory bowel diseases

How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

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