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

NCT07344324 | Not Yet Recruiting

• 1 other identifier: 7976
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief 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; Obesity; Insulin Resistant Diabetes (Mellitus)

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events Version 5.0

  Assessment of the safety and tolerability of the endoscopic duodenal injection of autologous adipose tissue-derived Mesenchymal Stem Cells. Safety will be evaluated by monitoring the frequency and severity of all adverse events and serious adverse events occurring during the study period.

  From the time of the endoscopic procedure through Month 12 post-procedure.

Secondary Outcomes (4)

• Change From Baseline in Glycated Hemoglobin at Month 12

  Baseline (Day 0) and Month 12.

• Change From Baseline in Total Daily Insulin Requirement at Month 12

  Baseline (Day 0) and Month 12.

• Change From Baseline in Fasting C-peptide Levels at Month 12

  Baseline (Day 0) and Month 12.

• Change From Baseline in Lipid Profile Parameters at Month 12

  Baseline (Day 0) and Month 12.

Study Arms (1)

15 participants with T2DM

EXPERIMENTAL

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

Procedure: endoscopic duodenal injection of ADMSCs

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.

15 participants with T2DM

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Fasting C-peptide ≥1 ng/ml
• Stable antidiabetic regimen for ≥3 months (including insulin s.c.)
• Insulin resistance (HOMA-IR \> 5)
• Healthy volunteers: BMI \< 25, age between 18-75 and no diagnosis of T2DM or insulin resistance (HOMA-IR\<2.5), with no significant acute or chronic medical conditions and not taking medications that could interfere with the esophagogastroduodenoscopy + biopsies

You may not qualify if:

• Type 1 DM or secondary diabetes
• Celiac disease
• History of pancreatitis or GI surgery
• Active infection or malignancies ongoing
• Active gastro-duodenal ulcers
• Duodenum not accessible endoscopically for previous surgery or other conditions
• History of autoimmune disease
• Active malignancy or recent cancer treatment
• Use of certain medications (e.g., immunosuppressants, systemic corticosteroids)
• Active Smoking (\>5 sigarettes/die)
• Anticoagulant treatment not suspendable
• Myocardial infarction during the past 6 months or/and heart failure class III or IV according to the New York Heart association's classification.
• Drug or alcohol abuse
• Continuous glucocorticoid or anti-inflammatory treatment
• Uncontrolled thyroid disease.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• IVO BOSKOSKI

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

IVO BOSKOSKI

CONTACT

+39 06 3015 6580; ivo.boskoski@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 15, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 15, 2026

Record last verified: 2025-12