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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 主要终点
- Number of Participants With Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events Version 5.0
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• 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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: endoscopic duodenal injection of ADMSCs (Procedure)
结局指标
主要结局
Number of Participants With Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events Version 5.0
时间窗: From the time of the endoscopic procedure through Month 12 post-procedure.
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.
次要结局
- 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.)