NCT00306085Unknown1 期
Autologous Bone Marrow Cell Treatment in Patients With Peripheral Atherosclerosis
University of Naples2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2005年4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
- 20
- 试验地点
- 2
- 主要终点
- Clinical and instrumental indexes of functional impairment of peripheral atherosclerosis.
研究概览
简要总结
Implantation of bone marrow cells, including endothelial progenitor cells, into ischemic limbs has been shown to improve collateral vessel formation. In the present study the safety and feasibility of autologous blood mononuclear cells implantation will be investigated in patients with severe peripheral atherosclerosis.Twenty cases will be enrolled. Improvement in the ankle-brachial pressure index (ABI:>0.1), ischemic ulcers and angiography as well as laser doppler flow will be evaluated until six months.
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
- Double
入排标准
- 年龄范围
- 45 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of third or fourth class of peripheral atherosclerosis
排除标准
- •Insuline dependent diabetes
结局指标
主要结局
Clinical and instrumental indexes of functional impairment of peripheral atherosclerosis.
次要结局
- Angiographic and laser doppler measurements after six months from treatment.
研究者
研究点 (2)
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