Crohn'sUCNot yet recruiting

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

Observational · No treatment assigned · 2 sites · IRCCS San Raffaele

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

Condition(s) listed: Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.

Who can join

Ages 2 to 18
Any sex
Healthy volunteers accepted

Some of the main requirements, copied from the record:

For all groups:
Written informed consent from parent(s)/legal guardian(s);
Sex: Males and Females;

Plus 8 more requirement(s). There are also 20 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

About 80 participants are expected to take part.
Start date: 2026-10 (planned).
Main results expected around 2029-10 (estimate from the record).
2 study sites listed in Italy.

Main thing being measured

To characterize pediatric IBD patients' peripheral blood and intestinal mucosa immune cell composition (Baseline timepoint)

In the researchers’ words

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…

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Am I likely to qualify, given my health history?
What would I have to do, and how often would I need to visit?
Could I get a placebo? What happens to my current treatment?
What are the possible risks and benefits?
Are travel or other costs covered?
What happens after the trial ends?

Official details

Status	Not yet recruiting
Phase	Observational
Study type	Observational
Conditions	Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis)
Lead sponsor	IRCCS San Raffaele
Enrollment	80 (estimated)
Start date	2026-10
Primary completion (est.)	2029-10
First posted	2026-07-31
Last updated	2026-07-31
Official title	Exploring and Exploiting the TOLerogenic Potential of Hematopoietic Stem and Progenitor Cells to Cure Pediatric Inflammatory Bowel Disease
ClinicalTrials.gov ID	NCT07740499

Interventions

biological sample collection: an additional volume of peripheral blood (3-10 ml) (Procedure)
An additional volume of peripheral blood (3-10 ml) will be obtained in concomitance with clinically indicated procedures
biological sample collection: small fragment (1-5 mm) of intestinal tissue - residual or leftover material (Procedure)
A small fragment (1-5 mm) of intestinal tissue - residual or leftover material -will be obtained from patients undergoing diagnostic or follow-up endoscopy
biological sample collection: leftover peripheral blood samples from healthy subjects (Procedure)
Peripheral blood samples from healthy subjects, leftover from TIGET09 protocol analysis will be collected

Full eligibility criteria (from the record)

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)

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

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.