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

Starting soon

Conditions studied: Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis)

In brief

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.

Key facts

Study ID: NCT07740499
Run by: IRCCS San Raffaele
People needed: 80
Starts: 2026-10-01
Expected to finish: 2029-11-01
Last updated by the study team: 2026-07-31

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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").

You may not qualify if…

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.

Where it is running

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

Full record on ClinicalTrials.gov

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