Menu
Not yet recruiting NCT07344324

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

No phase Interventional Diabete Type 2 Insulin Resistant Diabetes (Mellitus) Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: endoscopic duodenal injection of ADMSCs.
Who it may be relevant to
Registry conditions: Diabete Type 2, Insulin Resistant Diabetes (Mellitus), Obesity. Basic parameters: 25 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Overview

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.

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 substra

Primary outcome measures

  • 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.]
Secondary outcome measures (4)
  • Change From Baseline in Glycated Hemoglobin at Month 12 [Time frame: Baseline (Day 0) and Month 12.]
  • Change From Baseline in Total Daily Insulin Requirement at Month 12 [Time frame: Baseline (Day 0) and Month 12.]
  • Change From Baseline in Fasting C-peptide Levels at Month 12 [Time frame: Baseline (Day 0) and Month 12.]
  • Change From Baseline in Lipid Profile Parameters at Month 12 [Time frame: Baseline (Day 0) and Month 12.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07344324 · 7976

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗