NCT00919516已完成不适用
Use of Autologous Bone-Marrow Mononuclear Cell Implantation Therapy as a Limb Salvage Procedure in Patients With Moderate to Severe Peripheral Arterial Disease
The Vascular and Vein Center, Columbus, OH2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2007年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Major limb amputation
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of dual intramuscular and intra-arterial autologous bone marrow mononuclear cell implantation for the treatment of patients with moderate to severe peripheral arterial disease in whom amputation was considered the only viable treatment option.
Study Hypothesis: Patients with moderate to severe peripheral arterial disease who receive intramuscular and intra-arterial stem cell injections will have improved ankle brachial index (ABI) measurements; relief of rest pain; ulcer healing, if applicable; and absence of major limb amputations.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients at least 18 years of age.
- •Patients with moderate or severe limb-threatening PAD, defined as ankle brachial indices (ABI) less than 0.7 or presence of non-healing ischemic ulcers with stenosis or occlusion of two of the following lower extremity arteries: anterior tibial, posterior tibial, and peroneal.
- •Patients with conditions that preclude recommendation of traditional endovascular or open bypass treatments.
排除标准
- •Patients younger than 18 years of age.
- •Patients who are eligible to undergo traditional endovascular or open bypass for the treatment of PAD.
- •Female patients who are or may be pregnant.
- •Patients who are prisoners.
- •Patients with mental retardation or are unable to consent for participation independently.
结局指标
主要结局
Major limb amputation
时间窗: three months
次要结局
- Improved ABI measurements(three months)
- Relief of rest pain(three months)
- Ulceration healing(three months)
研究者
研究点 (2)
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