Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07344324
NA

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

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

25 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2026-02-02

Completion Date

2027-06-30

Last Updated

2026-01-15

Healthy Volunteers

Yes

Interventions

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.