TOLerogenic Potential of Hematopoietic Stem and Progenitor Cells and Inflammatory Bowel Disease
Key facts
- Where
- Milan and Rome, ItalySee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 18 years old?
Source: NCT07740499, who can take part
Where in Italy
- Pediatric Immunohematology Unit, IRCCS Ospedale San RaffaeleMilan, ItalyNo longer taking part
- UOC Pediatria, Azienda Ospedaliero-Universitaria Sant'AndreaRome, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- IRCCS San Raffaele
- Trial code
- NCT07740499
- Record updated
- 31 July 2026
- Original description
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.Read full original descriptionShow less
Exploring and Exploiting the TOLerogenic Potential of Hematopoietic Stem and Progenitor Cells to Cure Pediatric Inflammatory Bowel Disease
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.
Inclusion: 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: 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:; Subjects without rectal bleeding or with known inflammatory/autoimmune disorders of the gastrointestinal tract; For all groups:; 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:; Subjects without rectal bleeding or with known inflammatory/autoimmune disorders of the gastrointestinal tract; For study group 3:; patients belonging to study groups 1 and 2; patients with immunodeficiencies, autoimmune, inflammatory or genetic diseases; Age: <2 years and ≥18 years; Age: <2 years and ≥18 years; For all groups:; Refusal or inability of the parent(s) or legal guardian(s) to provide written informed consent; patients without IBD diagnosis or suspect; For study group 2:; Refusal or inability of the parent(s) or legal guardian(s) to provide written informed consent; patients without IBD diagnosis or suspect; For study group 2:; Lack of written consent for participation to TIGET09 study protocol; subjects with signs of systemic inflammation.