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

NCT ID NCT07740499

Not yet recruiting Knowledge-focused Sponsor: IRCCS San Raffaele Source: ClinicalTrials.gov ↗

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.

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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)

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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