Autologous Transplantation of Mesenchymal Stem Cells for Treatment of Patients With Onset of Type 1 Diabetes
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- C peptide release test
研究概览
简要总结
Type 1 diabetes mellitus (T1DM)is characterized by the autoimmune destruction of the pancreatic β cells; as a result, patients with T1DM are dependent on exogenous insulin to control their blood glucose continuously. Bone marrow-derived mesenchymal stem cells has been shown in many animal studies their potential cure for T1DM,which could not only address the need for β-cell replacement but also control of the autoimmune response to cells which express insulin. Therefore it is need to study the safety and efficacy of autologous bone marrow mesenchymal stem cells in treatment of newly diagnosed patients with T1DM.
详细描述
Autologous transplantation of Bone marrow mesenchymal stem cells(approximately 2.5 x 106 cells/kg body weight) intravenously
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 10 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide written informed consent from patients or Child guardian
- •Confirmed diagnosis of type 1 diabetes by ADA criteria less than 18 weeks •
排除标准
- •Body Mass Index >30
- •Presence of acute stage as Active infection,recent myocardial infarction, recent cerebral vascular accident (CVA) or acute renal failure.
- •Severe Organ damage(e.g. lung disease, or hematopoietic dysfunction, or liver dysfunction).
- •Infectious diseases, e.g. HIV infection, or hepatitis B or C infection
- •Presence of malignancy
研究组 & 干预措施
mesenchymal stem cells
To study the safety and efficacy of autologous transplantation of bone marrow mesenchymal stem cells in treatment of newly diagnosed patients with T1DM.
干预措施: Autologous transplantation (Biological)
结局指标
主要结局
C peptide release test
时间窗: 6 Months after intervention
The concentration of c-peptide at 90 minutes after the start of the C-peptide release test at 24 Months following the infusion or not with bone marrow mesenchymal stem cells
次要结局
未报告次要终点
研究者
Lu Debin
Southwest Hospital
Third Military Medical University