Clinical Trial

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

Study acronym: TOL-IBD
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07740499
Lead Sponsor IRCCS San Raffaele
Conditions Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis)
Enrollment 80 participants
Start Date 2026-10
Primary Completion 2029-10 (estimated)
Study Completion 2029-11 (estimated)
Updated on ClinicalTrials.gov 2026-07-31