Outcomes of Expanded Autologous Bone Marrow-derived Mesenchymal Stem Cells Therapy in Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of autologous bone marrow-derived mesenchymal stem cells transplantation in the treatment of type 2 diabetes mellitus
详细描述
Bone marrow-derived mesenchymal stem cells have the immunosuppressive effect and secrete a variety of cytokines, improve the microenvironment of diabetic patients, targeting insulin resistance tissue, ameliorate the metabolic disorder of islet damage, protect and regeneration of the islet beta cells; reduce high blood sugar.The purpose of this study is to evaluate the safety and effectiveness of autologous bone marrow-derived mesenchymal stem cells transplantation in treatment 30 patients with type 2 diabetes mellitus at Vinmec International Hospital, Hanoi, Vietnam
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females
- •Age from 18 years and above.
- •Hemoglobin A1c (HbA1c) is ranged from 7.5% to 9% at baseline.
- •Type 2 diabetes duration 5 years or more.
- •Before the screening, joint or combined with insulin, oral medications to treat more than 3 months.
- •Who signed the informed consent form.
排除标准
- •Type 1 diabetes.
- •Chronic disease or severe disease, including cancer, severe heart disease, kidney disease, liver disease, etc.
- •According to the medical doctor's judgement, may endanger the safety of the subjects
结局指标
主要结局
Adverse events
时间窗: up to the 12-month period following treatment
Number of adverse events in both groups
Insulin dose
时间窗: up to the 12-month period following treatment
Reduction of insulin dose requirement by ≥50% in both groups
次要结局
- Hemoglobin A1c (HbA1c) level(up to the 12-month period following treatment)