[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619415":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":20,"responsibleParty":30,"collaborators":20,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":38,"eligibilityCriteria":39,"healthyVolunteers":40,"sex":41,"minAge":42,"maxAge":43,"enrollmentInfo":44,"targetDuration":20,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":20,"overallStatus":55,"whyStopped":20,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":20},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"15 participants with T2DM","EXPERIMENTAL","Subjects with a BMI between ≥ 25 and ≤ 35 kg\u002Fm2, T2DM and age between 30-65 will be considered eligible for the study.",[13],"Procedure: endoscopic duodenal injection of ADMSCs",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","endoscopic duodenal injection of ADMSCs","Biopsy Protocol Mucosal biopsies (12 at baseline; 6 at follow-up) will be collected from the Treitz angle to the genu inferius. Samples for ex vivo analysis will be transported at 37°C in sterile medium within 15 minutes.\n\nADMSC Preparation and Delivery Autologous adipose tissue, harvested via mini-liposuction, will undergo mechanical activation (ELEA Method: 2000 rpm for 8 min). The activated fat is filtered (2 mm), emulsified, and loaded into a 19-gauge needle. Under deep sedation, the substrate will be injected submucosally from the Treitz angle to the superior duodenal genu, ensuring papilla preservation.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"IVO BOSKOSKI","PRINCIPAL_INVESTIGATOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","+39 06 3015 6580","ivo.boskoski@policlinicogemelli.it",{"type":31,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100619415","study-evaluating-the-safety-and-feasibility-of-endoscopic-duodenal-injections-of-autologous-mesenchymal-stem-cells-100619415",false,"NCT07344324","Study Evaluating the Safety and Feasibility of Endoscopic Duodenal Injections of Autologous Mesenchymal Stem Cells","A Pilot Study Evaluating the Safety, Feasibility, and Therapeutic Potential of Endoscopic Duodenal Injection of Adipose Tissue-Derived Mesenchymal Stem Cells in Patients With Type 2 Diabetes Mellitus.","STEM-DM","Inclusion Criteria:\n\n* • Adults aged between 25-70 years\n\n  * Diagnosis of T2DM from at least 1 years\n  * HbA1c between 7.5% and 10%\n  * BMI between 25 and 35 kg\u002Fm²\n  * Fasting C-peptide ≥1 ng\u002Fml\n  * Stable antidiabetic regimen for ≥3 months (including insulin s.c.)\n  * Insulin resistance (HOMA-IR \\> 5)\n  * Healthy volunteers: BMI \\\u003C 25, age between 18-75 and no diagnosis of T2DM or insulin resistance (HOMA-IR\\\u003C2.5), with no significant acute or chronic medical conditions and not taking medications that could interfere with the esophagogastroduodenoscopy + biopsies\n\nExclusion Criteria:\n\n* Type 1 DM or secondary diabetes\n* Celiac disease\n* History of pancreatitis or GI surgery\n* Active infection or malignancies ongoing\n* Active gastro-duodenal ulcers\n* Duodenum not accessible endoscopically for previous surgery or other conditions\n* History of autoimmune disease\n* Active malignancy or recent cancer treatment\n* Use of certain medications (e.g., immunosuppressants, systemic corticosteroids)\n* Active Smoking (\\>5 sigarettes\u002Fdie)\n* Anticoagulant treatment not suspendable\n* Myocardial infarction during the past 6 months or\u002Fand heart failure class III or IV according to the New York Heart association's classification.\n* Drug or alcohol abuse\n* Continuous glucocorticoid or anti-inflammatory treatment\n* Uncontrolled thyroid disease.\n* Pregnancy, breastfeeding\n* Psychiatric or cooperative problems or low compliance that is a contraindication from participating in the study.\n* Liver cirrhosis of any Child-Phugh stage or MELD\\> 15\n* Chronic Severe Renal Insufficiency (eGFR \\\u003C 30 ml\u002Fmin\u002F1.73 m2 based on CKD-EPI equation)\n* Currently participating in other study, or previously participated in an experimental drugs trial within 30 days before or 5 half-life of the drug administered\n* Any health issue that might put the patient at risk if the treatment is performed, judged by the investigator.",true,"ALL","25 Years","70 Years",{"count":45,"type":46},15,"ESTIMATED","INTERVENTIONAL",[49],"NA","Type 2 Diabetes Mellitus (T2DM) pathogenesis increasingly involves \"diabetic duodenopathy,\" characterized by proximal intestinal immune and epithelial dysregulation. This study investigates the endoscopic delivery of adipose-derived mesenchymal stem cells (ADMSCs) into the duodenum and proximal jejunum as a disease-modifying therapy. By leveraging the paracrine immunomodulatory and regenerative effects of ADMSCs in close proximity to the pancreatico-enteroendocrine system, this targeted approach aims to restore insulin sensitivity and $\\\\beta$-cell function while minimizing systemic exposure. The clinical safety and feasibility of this novel delivery route remain to be established.",[52,53,54],"Diabete Type 2","Insulin Resistant Diabetes (Mellitus)","Obesity","NOT_YET_RECRUITING","2026-01-07",{"date":58,"type":59},"2026-01-15","ACTUAL",{"date":61,"type":46},"2026-02-02",{"date":63,"type":46},"2027-06-30",{"name":5,"class":6}]