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NCT07740499

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

Sponsor: IRCCS San Raffaele

View on ClinicalTrials.gov

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.

Official title: Exploring and Exploiting the TOLerogenic Potential of Hematopoietic Stem and Progenitor Cells to Cure Pediatric Inflammatory Bowel Disease

Key Details

Gender

All

Age Range

2 Years - 18 Years

Study Type

OBSERVATIONAL

Enrollment

Start Date

2026-10

Completion Date

2029-11

Last Updated

2026-07-31

Healthy Volunteers

Yes

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

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.

Locations (2)

Pediatric Immunohematology Unit, IRCCS Ospedale San Raffaele

Milan, Italy

UOC Pediatria, Azienda Ospedaliero-Universitaria Sant'Andrea

Rome, Italy

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (2)