NCT00646724Unknown1 期
Cotransplantation of Islet and Mesenchymal Stem Cell in Type 1 Diabetic Patients
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Exogenous insulin requirement
研究概览
简要总结
The study evaluates the safety and efficacy of Cotransplantation of Islet and Mesenchymal Stem Cell in Type 1 Diabetic Patients. The researchers hypothesize that additional Mesenchymal Stem Cell infusion can benefit the promising clinical islet transplantation through the following mechanisms: protection of islet from inflammatory damage, immunological modulation, engraftment promotion, thus decrease or eliminate the need of exogenous insulin and improve β-cell function.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients age 18 to 60 years of age
- •Ability to provide written informed consent
- •Manifest signs and symptoms that are severe enough to be incapacitating
- •Patients with poor diabetes control (HbA1c > 7% but < 12%)
- •Progressive diabetic complications
排除标准
- •age < 18 years or > 60 years
- •diabetic history < 5 years
- •BMI > 27
- •body weight > 80 kg
- •exogenous insulin requirement > 1 unit/kg/day
- •severe anemia (male < 8 g/dl, female < 7 g/dl)
- •low white blood cell count (< 3000/dl)
- •liver dysfunction
- •Active infection including hepatitis B, hepatitis C, HIV, or TB
- •panel reactive antibody > 20%
- •Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial
研究组 & 干预措施
1
Experimental
cotransplantation of islet and mesenchymal stem cell
干预措施: cotransplantation of islet and mesenchymal stem cell (Biological)
结局指标
主要结局
Exogenous insulin requirement
时间窗: 5
Hemoglobin A1c
时间窗: 5
Glucose and C-peptide levels
时间窗: 5
次要结局
- liver function(5)
- kidney function(5)
- Portal vein Ultrasound(1)
- autoantibodies(5)
- Complete Blood Count(5)
研究者
研究点 (1)
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