[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649843":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":38,"centralContacts":45,"locations":54,"responsibleParty":86,"collaborators":10,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":97,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":10,"studyType":104,"phases":10,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":114,"whyStopped":10,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"IRCCS San Raffaele","OTHER",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Study Group 1",null,"IBD patients: pediatric patients with chronic intestinal inflammation (i.e., inflammatory bowel disease (IBD), including Crohn Disease, Ulcerative Colitis) at diagnosis or follow-up (including responders to standard of care and refractory to treatment)",[13,14],"Procedure: biological sample collection: an additional volume of peripheral blood (3-10 ml)","Procedure: biological sample collection: small fragment (1-5 mm) of intestinal tissue - residual or leftover material",{"label":16,"type":10,"description":17,"interventionNames":18},"Study Group 2","Non-IBD patients: patients with rectal bleeding with a negative colonoscopy and the exclusion of any inflammatory disorders of the gastrointestinal tract",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Study Group 3","Healthy volunteers (controls)",[23],"Procedure: biological sample collection: leftover peripheral blood samples from healthy subjects",[25,30,34],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"PROCEDURE","biological sample collection: an additional volume of peripheral blood (3-10 ml)","An additional volume of peripheral blood (3-10 ml) will be obtained in concomitance with clinically indicated procedures",[9,16],{"type":26,"name":31,"description":32,"armGroupLabels":33,"otherNames":10},"biological sample collection: small fragment (1-5 mm) of intestinal tissue - residual or leftover material","A small fragment (1-5 mm) of intestinal tissue - residual or leftover material -will be obtained from patients undergoing diagnostic or follow-up endoscopy",[9,16],{"type":26,"name":35,"description":36,"armGroupLabels":37,"otherNames":10},"biological sample collection: leftover peripheral blood samples from healthy subjects","Peripheral blood samples from healthy subjects, leftover from TIGET09 protocol analysis will be collected",[20],[39,43],{"name":40,"affiliation":41,"role":42},"Silvia Gregori, PhD","IRCCS Ospedale San Raffaele","PRINCIPAL_INVESTIGATOR",{"name":44,"affiliation":41,"role":42},"Alessandro Aiuti, MD",[46,50],{"name":40,"role":47,"phone":48,"phoneExt":10,"email":49},"CONTACT","+390226434894","gregori.silvia@hsr.it",{"name":51,"role":47,"phone":52,"phoneExt":10,"email":53},"Laura Passerini, PhD","+390226439303","passerini.laura@hsr.it",[55,72],{"facility":56,"status":10,"city":57,"state":10,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Pediatric Immunohematology Unit, IRCCS Ospedale San Raffaele","Milan","20132","Italy","IT",{"type":62,"coordinates":63},"Point",[64,65],9.18951,45.46427,{"lat":65,"lon":64},[68],{"name":69,"role":47,"phone":70,"phoneExt":10,"email":71},"Federica Barzaghi, MD","+390226432979","barzaghi.federica@hsr.it",{"facility":73,"status":10,"city":74,"state":10,"zip":75,"country":59,"countryCode":60,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"UOC Pediatria, Azienda Ospedaliero-Universitaria Sant'Andrea","Rome","00189",{"type":62,"coordinates":77},[78,79],12.51133,41.89193,{"lat":79,"lon":78},[82],{"name":83,"role":47,"phone":84,"phoneExt":10,"email":85},"Giovanni Di Nardo, MD","+390633775971","giovanni.dinardo@uniroma1.it",{"type":42,"investigatorFullName":87,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Silvia Gregori","Principal Investigator","100649843","tolerogenic-potential-of-hematopoietic-stem-and-progenitor-cells-and-inflammatory-bowel-disease-100649843",false,"NCT07740499","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","TOL-IBD","Inclusion Criteria:\n\nFor all groups:\n\n* Written informed consent from parent(s)\u002Flegal guardian(s);\n* Sex: Males and Females;\n* Age: ≥2 years and \\\u003C18 years.\n\nFor study group 1:\n\n\\- Subjects with suspected or confirmed IBD diagnosis.\n\nFor study group 2:\n\n\\- Subjects with rectal bleeding w\u002Fo inflammatory disorders of the gastrointestinal tract.\n\nFor study group 3:\n\n* Written consent for participation to TIGET09 study protocol;\n* 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\").\n\nExclusion Criteria:\n\nFor all groups:\n\n* Refusal or inability of the parent(s) or legal guardian(s) to provide written informed consent;\n* Age: \\\u003C2 years and ≥18 years;\n* 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;\n\nFor study group 1:\n\n\\- patients without IBD diagnosis or suspect;\n\nFor study group 2:\n\n\\- Subjects without rectal bleeding or with known inflammatory\u002Fautoimmune disorders of the gastrointestinal tract.\n\nFor all groups:\n\n* Refusal or inability of the parent(s) or legal guardian(s) to provide written informed consent;\n* Age: \\\u003C2 years and ≥18 years;\n* 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;\n\nFor study group 1:\n\n\\- patients without IBD diagnosis or suspect;\n\nFor study group 2:\n\n\\- Subjects without rectal bleeding or with known inflammatory\u002Fautoimmune disorders of the gastrointestinal tract.\n\nFor study group 3:\n\n* Lack of written consent for participation to TIGET09 study protocol;\n* patients belonging to study groups 1 and 2; patients with immunodeficiencies, autoimmune, inflammatory or genetic diseases;\n* subjects with signs of systemic inflammation.",true,"ALL","2 Years","18 Years",{"count":102,"type":103},80,"ESTIMATED","OBSERVATIONAL","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\u002Fwo 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.",[107],"Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis)",[109,110,111,112,113],"hematopoietic stem and progenitor cells (HSPCs)","immune tolerance","regulatory T cells","IL-10 producing cells","commensal-derived epitopes","NOT_YET_RECRUITING","2026-07-28",{"date":117,"type":118},"2026-07-31","ACTUAL",{"date":120,"type":103},"2026-10",{"date":122,"type":103},"2029-11",{"name":5,"class":6},2]