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.
• 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
Type 1 DM or secondary diabetes
Celiac disease
History of pancreatitis or GI surgery
Active infection or malignancies ongoing
Single group
endoscopic duodenal injection of ADMSCs
Procedure/SurgeryBiopsy 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.
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.
Change From Baseline in Glycated Hemoglobin at Month 12
Mean change from baseline in Glycated Hemoglobin (HbA1c) levels. This physiological parameter is used to evaluate the long-term control of blood sugar levels. The data will be aggregated as the mean change from the start of the study to the final follow-up.
Change From Baseline in Total Daily Insulin Requirement at Month 12
Mean change from baseline in the total daily dose of insulin required by the participant. The dose is measured in International Units per Kilogram per Day. This measure assesses if the treatment reduces the patient's dependence on external insulin.
Change From Baseline in Fasting C-peptide Levels at Month 12
Mean change from baseline in fasting C-peptide levels. This parameter is used as a surrogate marker for endogenous insulin production and pancreatic beta-cell function. It is measured in nanograms per milliliter.
Change From Baseline in Lipid Profile Parameters at Month 12
Mean change from baseline in lipid profile parameters, including Total Cholesterol, Low-Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), and Triglycerides. These physiological parameters are measured in milligrams per deciliter (mg/dL) to evaluate the metabolic impact of the Mesenchymal Stem Cell transplantation. Data will be aggregated as the mean change for each lipid component.
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