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

Официальное название

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.

Обзор

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.

Вмешательства

• Процедура 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

Первичные конечные точки

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

Вторичные конечные точки (4)

• Change From Baseline in Glycated Hemoglobin at Month 12 [Срок оценки: Baseline (Day 0) and Month 12.]
• Change From Baseline in Total Daily Insulin Requirement at Month 12 [Срок оценки: Baseline (Day 0) and Month 12.]
• Change From Baseline in Fasting C-peptide Levels at Month 12 [Срок оценки: Baseline (Day 0) and Month 12.]
• Change From Baseline in Lipid Profile Parameters at Month 12 [Срок оценки: Baseline (Day 0) and Month 12.]

Критерии участия

Критерии включения

• • 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07344324 · 7976

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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