NCT01219465Unknown1 期
Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion for Initial Type 1 Diabetes
Qingdao University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年9月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- C peptide release test
研究概览
简要总结
The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for initial type 1 diabetes is safe and effective.
详细描述
Type 1 diabetes mellitus (T1DM)is characterized by the autoimmune destruction of the pancreatic β cells.Patients require multiple daily insulin injections throughout their lives as well as close monitoring of their diet and blood sugar levels to prevent complications. The investigators hope umbilical cord Mesenchymal Stem Cells could not only address the need for β-cell replacement but also control of the autoimmune response to β cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of type 1 diabetes by ADA criteria less than 9 weeks.
- •Ability to provide written informed consent from patients or Child guardian.
排除标准
- •diabetic ketoacidosis.
- •evidence of retinopathy at baseline.
- •Body Mass Index >
- •Severe or acute organ damage.
- •Infectious diseases, e.g. HIV infection, or hepatitis B or C infection.
- •Severe psychiatric disorder.
- •Presence of malignancy.
结局指标
主要结局
C peptide release test
时间窗: 3 months
次要结局
- Immunologic reconstitution parameters(3 months)
- Exogenous insulin dose(3 months)
- blood glucose(3 months)
- glycosylated Hemoglobin A1c(3 months)
- Number of severe and documented hypoglycemic events(3 months)
研究者
研究点 (1)
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