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

NCT07740499 · tracked via the Priya Life Science Italy tracker

Sponsor

IRCCS San Raffaele

Phase

Observational

Started

2026-10

Last updated

2026-07-31

Condition(s) studied

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

Investigational drug(s) / intervention(s)

biological sample collection: an additional volume of peripheral blood (3-10 ml)biological sample collection: small fragment (1-5 mm) of intestinal tissue - residual or leftover materialbiological sample collection: leftover peripheral blood samples from healthy subjects

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

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

biological sample collection: leftover peripheral blood samples from healthy subjects: Peripheral blood samples from healthy subjects, leftover from TIGET09 protocol analysis will be collected

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.

Eligibility

Sex

ALL

Min age

2 Years

Max age

18 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

To characterize pediatric IBD patients' peripheral blood and intestinal mucosa immune cell composition — Baseline timepoint
Frequency (%) of predefined regulatory and inflammatory immune-cell subsets in peripheral blood and gut mucosa, including regulatory T cells (FOXP3+ Tregs and IL-10 producing Tr1 cells), T naïve/memory and effector cells, regulatory myeloid cells (DC-10), and inflammatory myeloid cells (cDC1 and cDC2), measured by flow cytometry. The primary objective will be considered met if patients with IBD show a lower frequency of IL-10-producing cells than controls, with the estimated between-group difference supporting a defect in IL-10-producing cell responses.

Trial sites (2)

Facility	City	Region	Status
Pediatric Immunohematology Unit, IRCCS Ospedale San Raffaele	Milan	Italy
UOC Pediatria, Azienda Ospedaliero-Universitaria Sant'Andrea	Rome	Italy

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07740499 on ClinicalTrials.gov ↗ ← All trials in Italy