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.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 25 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabete Type 2
• Insulin Resistant Diabetes (Mellitus)
• Obesity

Interventions

Type	Name	Description
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. ADMSC 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.

Timeline

• Start date: 2026-02-02
• Primary completion: 2027-02-02
• Completion: 2027-06-30
• First posted: 2026-01-15
• Last updated: 2026-01-15