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

NCT ID: NCT07344324

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-02
• Study Completion Date: 2027-06-30

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; Insulin Resistant Diabetes (Mellitus); Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

endoscopic duodenal injection of ADMSCs

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• • 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

Exclusion Criteria

• 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.
• Pregnancy, breastfeeding
• Psychiatric or cooperative problems or low compliance that is a contraindication from participating in the study.
• Liver cirrhosis of any Child-Phugh stage or MELD> 15
• Chronic Severe Renal Insufficiency (eGFR < 30 ml/min/1.73 m2 based on CKD-EPI equation)
• Currently participating in other study, or previously participated in an experimental drugs trial within 30 days before or 5 half-life of the drug administered
• Any health issue that might put the patient at risk if the treatment is performed, judged by the investigator.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

IVO BOSKOSKI

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Central Contacts

IVO BOSKOSKI

Role: CONTACT

ivo.boskoski@policlinicogemelli.it

+39 06 3015 6580

Other Identifiers

7976

Identifier Type: -

Identifier Source: org_study_id