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TOLerogenic Potential of Hematopoietic Stem and Progenitor Cells and Inflammatory Bowel Disease

NCT07740499 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2026-07-31

No results posted yet for this study

Summary

Pediatric refractory Inflammatory Bowel Disease (IBD) is a chronic inflammatory condition of the gastrointestinal tract, not responsive to current treatments. Since hematopoietic stem and progenitor cells (HSPCs) in the bone marrow display immunomodulatory functions and IL-10-producing regulatory cells regulate gut homeostasis, by combining state-of-the-art strategies for the ex-vivo manipulation and expansion of HSPCs and gene delivery systems to drive HLA-class II-restricted antigen presentation and expression of tolerogenic molecules, the investigators propose to dissect the antigen- (Ag-) presenting capacity of HSPCs and to exploit their tolerogenic potential to induce IL-10-mediated tolerance in the intestinal mucosa of IBD patients. The investigators hypothesize that HSPCs can be engineered using commensal-derived Ags w/wo IL-10 to drive the differentiation of Tr1 cells with the desired Ag-specificity to control intestinal inflammation in IBD. The results of this study will pave the way for defining innovative cell-based approaches for treating refractory pediatric IBD.

Conditions

  • Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis)

Interventions

PROCEDURE

biological sample collection: an additional volume of peripheral blood (3-10 ml)

An additional volume of peripheral blood (3-10 ml) will be obtained in concomitance with clinically indicated procedures

PROCEDURE

biological sample collection: small fragment (1-5 mm) of intestinal tissue - residual or leftover material

A small fragment (1-5 mm) of intestinal tissue - residual or leftover material -will be obtained from patients undergoing diagnostic or follow-up endoscopy

PROCEDURE

biological sample collection: leftover peripheral blood samples from healthy subjects

Peripheral blood samples from healthy subjects, leftover from TIGET09 protocol analysis will be collected

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • Silvia Gregori, PhD · IRCCS Ospedale San Raffaele

  • Alessandro Aiuti, MD · IRCCS Ospedale San Raffaele

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2029-10-31
Completion
2029-11-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07740499 on ClinicalTrials.gov