Efficacy of Autologous Bone Marrow Mononuclear Cell Transplantation in Treating Selective Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,026
- 试验地点
- 1
- 主要终点
- C-peptide
研究概览
简要总结
The study is aimed to evaluate the safety and efficiency of autologous bone marrow mononuclear cell transplantation in treating selective patients with type 2 Diabetes Mellitus. We hypothesized that autologous bone marrow stem cell transplantation would promote β-cells regeneration by directly differentiated from the transplanted BMMCs or stimulate local stem cells regeneration and thus decrease or eliminate the need of exogenous insulin and improve β-cells function.
详细描述
To study the safety and efficacy of bone marrow mononuclear cell transplantation in type 2 diabetics. According to the intervention and baseline characteristics, patients are divided into 4 arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus
- •age 30-70
- •stable doses of medication for at least 3 months
- •BMI <35 and >18.5
排除标准
- •secondary cause for hyperglycemia
- •pregnancy or nursing
- •positive autoimmune antibody of diabetes
- •severe complication or concurrent diseases
- •active infection or febrile illness
- •allergy to iodine
- •history or signs of aortic aneurysm
- •history or active pancreatic diseases
- •known substance abuse or alcoholism or heavy smoking
- •not suitable for other conditions upon investigators' expertise
结局指标
主要结局
C-peptide
时间窗: 1 year
次要结局
- HbA1c(1 year)
- adverse event(1 year)
- reduction of medication(1 year)
研究者
Lei Lei, MD
Endocrinologist
Peking University Aerospace Center Hospital