NCT07740499Not yet recruiting
TOLerogenic Potential of Hematopoietic Stem and Progenitor Cells and Inflammatory Bowel Disease
Exploring and Exploiting the TOLerogenic Potential of Hematopoietic Stem and Progenitor Cells to Cure Pediatric Inflammatory Bowel Disease
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 80 (estimated)
- First submitted
- 23 Jul 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 31 Oct 2029
- Lead sponsor
- IRCCS San Raffaele
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT07740499
What you commit to
- Study type: Observational
- Planned participants: 80
- From 1 Oct 2026 to the primary completion date, 31 Oct 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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:
- 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:
- patients belonging to study groups 1 and 2; patients with immunodeficiencies, autoimmune, inflammatory or genetic diseases;
Age
- Age: \<2 years and ≥18 years;
- Age: \<2 years and ≥18 years;
Other
- For all groups:
- Refusal or inability of the parent(s) or legal guardian(s) to provide written informed consent;
- Refusal or inability of the parent(s) or legal guardian(s) to provide written informed consent;
- Lack of written consent for participation to TIGET09 study protocol;
- subjects with signs of systemic inflammation.
Who the study is looking for
- 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").
Age in the registry: 2 years to 18 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pediatric Immunohematology Unit, IRCCS Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| UOC Pediatria, Azienda Ospedaliero-Universitaria Sant'Andrea Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.