NCT02089828Unknown不适用
Randomized Control Trial on Purified CD34+ Cells Versus Peripheral Blood Mononuclear Cells in Treatment of Critical Limb Ischemia
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- major-amputation-free survival rate
研究概览
简要总结
To compare the efficacy and cost-effectiveness between purified CD34+ cells and peripheral blood mononuclear cells in treatment of critical limb ischemia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rutherford scale of 4-5
- •thromboangiitis obliterans, peripheral arterial disease, or arteritis caused by other etiologies, such as collagen diseases
- •surgical or endovascular procedures are considered unlikely to have successful long-term revascularization, or have failed
- •more than 4 weeks of critical limb ischemia
- •if present, a non-healing ulcer after more than 4 weeks of optimal care by a wound care physician and a nurse
排除标准
- •within 3 months of an acute myocardial infarction
- •any contraindication for the administration of granulocyte colony stimulating factor (G-CSF)
研究组 & 干预措施
autologous purified CD34+ cell
Experimental
transplantation of autologous purified CD34+ cell
干预措施: autologous purified CD34+ cells (Other)
autologous PB-MNC
Active Comparator
transplantation of autologous peripheral blood mononuclear cells
干预措施: autologous peripheral blood mononuclear cells (Other)
结局指标
主要结局
major-amputation-free survival rate
时间窗: at 6 months
次要结局
- improvement on transcutaneous partial oxygen pressure(at 3 months)
研究者
研究点 (1)
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