NCT00488020Unknown1 期
the Use of Autogenous Adult Stem Cells in the Treatment of Critical Ischemia
Instituto de Molestias Cardiovasculares2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2006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
- 10
- 试验地点
- 2
- 主要终点
- Suppress pain and heal ischemic ulcers
研究概览
简要总结
Collection of bone marrow blood Selection of mononuclear cells dilution with albumin injection into the calf muscles through 40 shots
详细描述
About 500cc of blood are collected from the iliac bone marrow under epidural anesthesia.In the cell therapy lab this blood is harvested and mononuclear cells are separated.This procedure takes roughly 4 hours.After dilution in albumin (40cc)the mononuclear cells are injected into the calf muscles through 40 shots.This procedure is indicated for patients with lower limb ischemia on whom all the others known therapies have failed
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fontaine's classification grade 3 and 4 patients
排除标准
- •Record of cancer in the last 5 years
- •Over 80 years
- •Diabetic retinopathy
结局指标
主要结局
Suppress pain and heal ischemic ulcers
时间窗: 6 months
次要结局
- improve quality of life(6 months)
研究者
研究点 (2)
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