NCT01663376已完成不适用
Effects of Adipose Tissue Derived Stem Cells Implantation in Patients With Critical Limb Ischemia
R-Bio2 个研究点 分布在 2 个国家目标入组 20 人开始时间: 2009年1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
- 20
- 试验地点
- 2
- 主要终点
- Major Adverse Events Analysis (MAEs)
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with critical limb ischemia
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 6 months since the onset CLI(Chronic ASO or Buerger disease)
- •Patients with luminal stenosis > 50% by leg angiography
- •Age is between 20 and 80
- •Patients whose Rutherford's class is II-4, III-5 or III-6 (Patients with rest pain or ischemic ulcer/necrosis)
- •Patients for whom angioplasty and bypass surgery are not indicated because of anatomical or procedural reasons or frequent reocclusion/restenosis following traditional revascularization
- •Patients who can give informed consent themselves in writing
排除标准
- •Previous or current history of neoplasm or comorbidity that could impact the patient's survival
- •Detection of proximal source of emboli including atrial fibrillation
- •Primary hematologic disease, including hypercoagulable states
- •Detection of proliferative retinopathy
- •Entrapment syndrome
- •Alcohol abuse, cocaine amphetamine etc.
- •Detection of osteomyelitis
- •Uncontrolled DM
结局指标
主要结局
Major Adverse Events Analysis (MAEs)
时间窗: 48 weeks
To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs
次要结局
- Digital subtraction angiography (DSA)(48 weeks)
- Ankle-Brachial Index (ABI)(48 weeks)
- Thermography(48 weeks)
- Wong-Baker FACES Pain Rating Score(48 weeks)
- Treadmill test(48 weeks)
研究者
研究点 (2)
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