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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-70
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

Qualifiers

• 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

Disqualifiers

Type 1 DM or secondary diabetes

Celiac disease

History of pancreatitis or GI surgery

Active infection or malignancies ongoing

Trial design

Treatments tested in this trial

  • endoscopic duodenal injection of ADMSCs

Treatment groups

15 Participants
are divided into 1 treatment group

Locations

This trial has no locations