NCT01028794已完成1 期
Phase 1/2A Study of Intravenous Autologous Bone Marrow Mononuclear Cell Transplantation for Patients After Cerebral Embolism
National Cerebral and Cardiovascular Center, Japan2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2008年5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
- 12
- 试验地点
- 2
- 主要终点
- Improvement of NIHSS（National Institute of Health Stroke Scale）
研究概览
简要总结
The purpose of this study is to determine whether autologous bone marrow mononuclear cells transplantation after stroke is safe and/or effective to improve neurological outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with cerebral embolism.
- •NIHSS score is more than (or equal to)
- •On day 7 after onset of stroke, the improvement of NIHSS is less than (or equal to) 5, compared with the level at administration.
- •Bone marrow aspiration can be done in 10 days after onset of stroke
排除标准
- •Patient with cerebral hemorrhage or symptomatic hemorrhagic infarction.
- •Patient who expects brain surgery.
- •Patient with acute myocardial infarction.
- •Patient with coagulation disorder.
- •Number of Platelet < 100000/mm3
- •Serum creatinine level >2.0mg/dl
- •Patient with malignancy.
- •Patient with uncontrolled proliferative diabetic retinopathy.
- •Patient suspected infective endocarditis.
- •HBV, HCV, HIV or HTLV positive
结局指标
主要结局
Improvement of NIHSS（National Institute of Health Stroke Scale）
时间窗: 30 days after treatment
Frequency of change for the worse in NIHSS
时间窗: 30 days aftrer treatment
次要结局
- Mean level of mRS (modified Rankin Scale)(30 days after treatment)
- Frequency of death(day 30 after treatment)
研究者
Akihiko Taguchi
guest investigator
National Cerebral and Cardiovascular Center, Japan
研究点 (2)
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