NCT01833585已完成3 期
Pilot Study of Treatment of Chronic Critical Limb Ischemia With G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Number of patients without major amputation after mononuclear cell injection
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of G-CSF-mobilized autologous peripheral blood mononuclear cell injection to ischemic limbs of patients with critical limb ischemia.
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
- •Patients with critical limb ischemia confirmed by toe pressure, ABI, TCOM
- •Levels of arterial occlusion are femoropopliteal or tibioperoneal occlusion
- •Poor distal artery runoff
- •Age 18-70 year
排除标准
- •Planned for major amputation within 4 weeks
- •Receive blood component within 4 weeks
- •Acute myocardial infarction
- •severe valvular heart disease
- •renal failure
- •liver failure
- •Hypercoagulable state
- •Severe infection
- •Pregnancy
研究组 & 干预措施
peripheral blood mononuclear cells
Experimental
peripheral blood mononuclear cells will be injected to calf muscle of critical limb ischemia
干预措施: Peripheral blood mononuclear cell (Biological)
结局指标
主要结局
Number of patients without major amputation after mononuclear cell injection
时间窗: 3 month
次要结局
未报告次要终点
研究者
研究点 (2)
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