Study Evaluating the Safety and Feasibility of Endoscopic Duodenal Injections of Autologous Mesenchymal Stem Cells

Inclusion Criteria: * • Adults aged between 25-70 years * Diagnosis of T2DM from at least 1 years * HbA1c between 7.5% and 10% * BMI between 25 and 35 kg/m² * Fasting C-peptide ≥1 ng/ml * Stable antidiabetic regimen for ≥3 months (including insulin s.c.) * Insulin resistance (HOMA-IR \> 5) * Healthy volunteers: BMI \< 25, age between 18-75 and no diagnosis of T2DM or insulin resistance (HOMA-IR\<2.5), with no significant acute or chronic medical conditions and not taking medications that could interfere with the esophagogastroduodenoscopy + biopsies Exclusion Criteria: * Type 1 DM or secondary diabetes * Celiac disease * History of pancreatitis or GI surgery * Active infection or malignancies ongoing * Active gastro-duodenal ulcers * Duodenum not accessible endoscopically for previous surgery or other conditions * History of autoimmune disease * Active malignancy or recent cancer treatment * Use of certain medications (e.g., immunosuppressants, systemic corticosteroids) * Active Smoking (\>5 sigarettes/die) * Anticoagulant treatment not suspendable * Myocardial infarction during the past 6 months or/and heart failure class III or IV according to the New York Heart association's classification. * Drug or alcohol abuse * Continuous glucocorticoid or anti-inflammatory treatment * Uncontrolled thyroid disease. * Pregnancy, breastfeeding * Psychiatric or cooperative problems or low compliance that is a contraindication from participating in the study. * Liver cir…