[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629781":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":49,"collaborators":20,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":20,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":20,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Ospedale San Raffaele","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Biospecimen Collection for iPSC Generation and β Cell Differentiation","EXPERIMENTAL","All participants will provide a single biological sample (skin biopsy, blood draw, or urine collection) for isolation of somatic cells. These cells will be reprogrammed into induced pluripotent stem cells (iPSCs) and differentiated into insulin-producing β cells to study pancreatic function and disease mechanisms. No therapeutic intervention is administered.",[13],"Procedure: Biological - skin biopsy, blood draw, or urine collection for iPSC generation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Biological - skin biopsy, blood draw, or urine collection for iPSC generation","This study involves a single, minimally invasive biological sampling to obtain somatic cells for the generation of induced pluripotent stem cells (iPSCs). Each participant will undergo only one procedure: a 3 mm skin punch biopsy under local anesthesia, a peripheral blood draw (up to 20 mL), or a urine collection (up to 300 mL), depending on laboratory needs. Samples will be processed to isolate fibroblasts, blood cells, or urine-derived epithelial cells, which will be reprogrammed into iPSCs using a non-integrating RNA-based system . The resulting iPSCs will be characterized for pluripotency and differentiated into insulin-producing β cells.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Valeria Sordi, PhD","CONTACT","+390226432643","sordi.valeria@hsr.it",[28],{"facility":29,"status":30,"city":31,"state":20,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Diabetes Research Institute","RECRUITING","Milan","20132","Italy","IT",{"type":36,"coordinates":37},"Point",[38,39],9.18951,45.46427,{"lat":39,"lon":38},[42,43,46,47],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"name":44,"role":45,"phone":20,"phoneExt":20,"email":20},"Lorenzo Piemonti, MD","PRINCIPAL_INVESTIGATOR",{"name":23,"role":45,"phone":20,"phoneExt":20,"email":20},{"name":48,"role":45,"phone":20,"phoneExt":20,"email":20},"Graziano Barera, MD",{"type":45,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Lorenzo Piemonti","Professor of Endocrinology Director, Diabetes Research Institute, Director, Regenerative Medicine and Transplant Unit","100629781","production-of-stem-cells-for-the-generation-of-pancreatic-cells-100629781",false,"NCT07479134","Production of Stem Cells for the Generation of Pancreatic Cells","Production Of Induced Pluripotent Stem Cells (iPSCs) For The Generation Of Insulin-Producing β Cells","Inclusion Criteria:\n\nAge between 12 and 70 years.\n\nAbility and willingness to provide informed consent (or assent with parental consent for minors).\n\nGroup 1: Individuals diagnosed with pancreatic β cell dysfunction, including but not limited to:\n\nType 1 Diabetes\n\nType 2 Diabetes\n\nMaturity Onset Diabetes of the Young (MODY)\n\nWolfram Syndrome\n\nPancreatogenic Diabetes\n\nGroup 2: Healthy control donors without pancreatic β cell dysfunction.\n\nPregnant or breastfeeding women may be included if they meet the inclusion criteria.\n\nExclusion Criteria:\n\nAge below 12 or above 70 years.\n\nHealth condition too compromised to allow safe tissue collection (e.g., acute hypoglycemia \\\u003C70 mg\u002FdL or hyperglycemia \\>140 mg\u002FdL at sampling).\n\nInability or unwillingness to provide informed consent\u002Fassent.\n\nActive malignancy or current cancer treatment.\n\nKnown infection with HIV, Hepatitis B, or Hepatitis C.\n\nUse of medications that may interfere with iPSC generation (e.g., high-dose corticosteroids, immunomodulators), unless approved by investigators.\n\nFor participants undergoing skin biopsy: bleeding disorders, local skin infection, allergy to anesthetics, or use of anticoagulants.",true,"ALL","12 Years","70 Years",{"count":64,"type":65},100,"ESTIMATED","INTERVENTIONAL",[68],"NA","The goal of this interventional study is to generate induced pluripotent stem cells (iPSCs) from somatic cells and differentiate them into insulin-producing β cells in patients with metabolic and genetic pancreatic diseases and in healthy controls. The main questions it aims to answer are:\n\nCan somatic cells from healthy individuals and patients with diabetes be successfully reprogrammed into iPSCs?\n\nCan these iPSCs be differentiated into functional insulin-producing β cells suitable for studying disease mechanisms and developing cell-based therapies?\n\nParticipants will provide a single biological sample (either a 3 mm skin punch biopsy, a blood sample, or a urine sample) collected under sterile conditions. The samples will be used to derive somatic cells, which will then be reprogrammed into iPSCs and differentiated into β cells for laboratory analyses.\n\nParticipants will:\n\nUndergo a one-time sample collection (skin biopsy, blood draw, or urine collection) at Ospedale San Raffaele\n\nReceive standard post-procedure care (if applicable)\n\nThis research aims to improve understanding of β cell function and dysfunction in diabetes and to advance personalized regenerative therapies for β cell replacement.",[71],"Diabetes",[73],"diabetes; stem cells, induced pluripotent stem cells","2026-03-13",{"date":76,"type":77},"2026-03-18","ACTUAL",{"date":79,"type":65},"2026-03-01",{"date":81,"type":65},"2036-02-28",{"name":5,"class":6},1]