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

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ID
NCT07344324
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
25 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • endoscopic duodenal injection of ADMSCs — PROCEDURE
    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.

Study Details

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.

Key Dates

First listed
Jan 15, 2026
Start date
Oct 2, 2026
Status verified
Dec 2025
Primary completion
Oct 2, 2027
Completion
Oct 30, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 15 participants with T2DM
    Subjects with a BMI between ≥ 25 and ≤ 35 kg/m2, T2DM and age between 30-65 will be considered eligible for the study.

Primary Outcome Measure

Number of Participants With Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events Version 5.0 [ Time Frame: From the time of the endoscopic procedure through Month 12 post-procedure. ]

Central Contacts

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