NCT00616980已完成1 期
Injection of Autologous CD34-Positive Cells for Improved Symptomatic Relief and Ischemic Wound Healing in Subjects With Moderate or High-Risk Critical Limb Ischemia
Losordo, Douglas, M.D.23 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2007年12月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 23
- 主要终点
- Safety of Intramuscular Injection of CD34-positive cells
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of intramuscular injections of adult stem cells in patients with Critical Limb Ischemia (CLI).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21-80 years of age
- •moderate or high-risk Critical Limb Ischemia (Rutherford Clinical Severity Score 4 or 5)
- •unsuitable for conventional revascularization
排除标准
- •advanced CLI (Rutherford Clinical Severity Score 6) characterized by extensive tissue loss or gangrene
- •advance AV block or NYHA Class III or Class IV heart failure
- •myocardial infarction within 3 months of treatment
- •successful coronary or lower extremity revascularization within 3 months of study enrollment
- •arterial insufficiency in the lower extremity is the result of a non-atherosclerotic disorder with the exception of thromboangitis obliterans (Buerger's Disease)
- •co-morbidity associated with life expectancy of less than 1 year
结局指标
主要结局
Safety of Intramuscular Injection of CD34-positive cells
时间窗: 6 months and 1 year
Change in Rest Pain
时间窗: 6 months
Ulcer Healing
时间窗: 6 months
Functional Improvement
时间窗: 6 months
Limb Salvage
时间窗: 6 months
次要结局
- Disease Severity(6 months)
- Assessment of Co-morbidity(6 months)
研究者
研究点 (23)
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