Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Absence of new neurological deficits and adverse effects during the timeframe.
研究概览
简要总结
The aim of the study is to determine the safety and efficacy on an autologous CD34+ subset bone marrow stem cell infusion into the middle cerebral artery in patients who have suffered acute middle cerebral artery stroke.
详细描述
The proposed trial will involve the recruitment of a total of 20 patients.
The cells will be collected from ten subject recruited as cases, via bone marrow sampling. The aspirate will be centrifuged on a Ficoll density gradient to isolate mononuclear cells, which will be resuspended in heparinized isotonic saline for infusion into the area of the stroke intra-arterially using the middle cerebral artery.
The investigators will monitor each case and control for a period of 6 months post-stem cell infusion. Initially, they will be subjected to a review after one month,three months and finally 6 months.
Assessment of adverse events will be by physical examination and measurement of laboratory parameters. Assessment of efficacy will be by physical examination and the measurement of laboratory, CT and MRI parameters.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms and signs of clinically definite middle cerebral artery acute stroke.
- •Time of stroke onset is known and treatment can be started between day 5 and 9 of onset.
- •DWI-MRI has reliably shown relevant acute ischemic lesions
- •Extracranial duplex/transcranial Doppler must confirm intra/extracranial arteries permeability.
- •The stroke is severe (NIH Stroke Scale >= 8 before procedure).
- •An age range of 18-80 years old.
排除标准
- •Patients out of inclusion age range.
- •Lacunar infarction.
- •Patients with cancer.
- •Patients with present or previous malignant disease during the last 5 years, except for basal cell carcinoma.
- •Hematological causes of stroke.
- •Severe co-morbidity.
- •Hepatic or renal dysfunction.
- •The patient is female and of childbearing potential (unless it is certain that pregnancy is not possible) or breast feeding.
- •Patient is likely to be unavailable for follow-up.
- •Patient with evidence of life threatening infection of life threatening illness.
- •Patient was already dependent in activities of daily living before the present acute stroke.
结局指标
主要结局
Absence of new neurological deficits and adverse effects during the timeframe.
时间窗: Duration of study
次要结局
- Improvement in clinical function as assessed by the Modified Rankin Score, Barthel Scale and NIH stroke scale.(Duration of study)