NCT00442143Unknown1 期
Treatment of Severe Limb Ischemia With Autologous Bonemarrow Derived Mononuclear Cells
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Transcutaneous oxygen pressure
研究概览
简要总结
The aim of the study is to investigate whether implantation of autologous bone marrow derived stem cells in ishemics limbs will improve vascularization
详细描述
10 patients with severe lower limb ischemia will be included in this pilote trial.
Bonemarrow aspiration will be performed and and the monocuclear cells isolated an injected into the gastrocnemius.
The patiens are followed for 4 months. Were trancutaneous oxygenpressure, ankel and toe blood pressure is measured.
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
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ankle blood pressure < 70 mmgHG
- •Either pain at rest and/or ischemic wound
- •No possible surgical treatment
排除标准
- •Infection
- •Malignant disease
结局指标
主要结局
Transcutaneous oxygen pressure
1st toe blood pressure (strain gauge)
Ankle blood pressure
Wound healing
Pain
次要结局
- amputation
- Infection
研究者
研究点 (2)
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