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Rewiring the immune system: a new hope for children with severe IBD?

NCT ID NCT07740499

Knowledge-focused Sponsor: IRCCS San Raffaele 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This study investigates why children with inflammatory bowel disease (IBD) have an overactive immune response in the gut, and whether blood stem cells can be engineered to restore tolerance. Researchers will analyze blood and intestinal tissue samples from 80 children with IBD, with gastrointestinal bleeding, and healthy controls to compare immune cell profiles. In the lab, they will test whether stem cells modified to present gut bacteria antigens can coax immune cells into becoming regulatory T cells that calm inflammation. The findings could inform future cell-based therapies for refractory pediatric IBD.

What this could mean

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

Active substance
Engineered hematopoietic stem and progenitor cells (HSPCs) designed to present gut bacteria antigens and promote immune tolerance
What this could lead to
If successful, this research could lay the groundwork for a cell-based therapy that teaches the immune system to tolerate gut bacteria, potentially offering a new way to treat refractory pediatric inflammatory bowel disease.
What could go wrong
This is an early-stage exploratory study focused on understanding immune mechanisms, not yet testing a treatment in patients. The engineered cells are only studied in the lab, and many years of further research would be needed before any clinical application.

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.

Participants

About 80 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Nov 2029

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.

Who is studied

Eligible participants will be consecutively enrolled as they present to the clinical centers until the planned sample size is achieved. The Study will include pediatric subjects, both males and females belonging to the following study populations: 1. IBD patients: pediatric patients with chronic intestinal inflammation (i.e., inflammatory bowel disease (IBD), including Crohn Disease, Ulcerative Colitis) at diagnosis or follow-up (including responders to standard of care and refractory to treatment); 2. Non-IBD patients: patients with rectal bleeding with a negative colonoscopy and the exclusion of any inflammatory disorders of the gastrointestinal tract; 3. Healthy controls: healthy volunteers participating in the TIGET09 study protocol ("Collection of biological samples for the study of blood cells and their microenvironment, and for the development of novel therapeutic approaches for genetic diseases and cancer."), as control population.

Ages

2 to 18 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: For all groups: * Written informed consent from parent(s)/legal guardian(s); * Sex: Males and Females; * Age: ≥2 years and \<18 years. For study group 1: \- Subjects with suspected or confirmed IBD diagnosis. For study group 2: \- Subjects with rectal bleeding w/o inflammatory disorders of the gastrointestinal tract. For study group 3: * Written consent for participation to TIGET09 study protocol; * healthy subjects, without known immunodeficiencies, autoimmune, inflammatory or genetic diseases, undergoing genetic, hematological, hematochemical, or HLA compatibility screenings and participating in the TIGET09 study protocol (Title: "Collection of biological samples for the study of blood cells and their microenvironment, and for the development of novel therapeutic approaches for genetic diseases and cancer"). Exclusion Criteria: For all groups: * Refusal or inability of the parent(s) or legal guardian(s) to provide written informed consent; * Age: \<2 years and ≥18 years; * Presence of any medical, psychiatric, or clinical condition that, in the opinion of the clinician, may interfere with participation in the study or interpretation of the study results; For study group 1: \- patients without IBD diagnosis or suspect; For study group 2: \- Subjects without rectal bleeding or with known inflammatory/autoimmune disorders of the gastrointestinal tract. For all groups: * Refusal or inability of the parent(s) or legal guardian(s) to provide written informed consent; * Age: \<2 years and ≥18 years; * Presence of any medical, psychiatric, or clinical condition that, in the opinion of the clinician, may interfere with participation in the study or interpretation of the study results; For study group 1: \- patients without IBD diagnosis or suspect; For study group 2: \- Subjects without rectal bleeding or with known inflammatory/autoimmune disorders of the gastrointestinal tract. For study group 3: * Lack of written consent for participation to TIGET09 study protocol; * patients belonging to study groups 1 and 2; patients with immunodeficiencies, autoimmune, inflammatory or genetic diseases; * subjects with signs of systemic inflammation.

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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 disease (Crohn's disease; ulcerative colitis)

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

  • Pediatric Immunohematology Unit, IRCCS Ospedale San Raffaele

    Milan, 20132, Italy

  • UOC Pediatria, Azienda Ospedaliero-Universitaria Sant'Andrea

    Rome, 00189, Italy

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