Clinical Trial

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

Study acronym: STEM-DM
Not Yet Recruiting
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Summary
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.
Trial Details
NCT Number NCT07344324
Lead Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions Diabete Type 2, Insulin Resistant Diabetes (Mellitus), Obesity
Enrollment 15 participants
Start Date 2026-02-02
Primary Completion 2027-02-02 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-15