An Exploratory Clinical Trial to Assess Treatment of Chronic Ischemic Stroke With Brain Transplants of Purified CD34+ Umbilical Cord Blood Stem Cells
试验速览
- 阶段
- 1 期
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Change from Baseline in NIH Stroke Scale(NIHSS)
研究概览
简要总结
The purpose of the study is to determine the safety and possible effectiveness of brain transplants of CD34+ stem cells obtained from umbilical cord blood (UCB) to treat stroke.
详细描述
The study will use CD34+ cells (a special kind of cell that is believed to be a stem cell) isolated from UCB (blood obtained at birth from the umbilical cord blood of babies). StemCyte, a leading accredited UCB banking company with branches in the United States and Taiwan, will provide the units of UCB that match at least 5 out of 6 HLA (human leukocyte antigens) for transplantation. The HLA-matching is the same as that used to match cells and organs for transplantation so that the body does not reject the cells. We will isolate CD34 cells from these units, purified them, suspend the cells in solution (1 ml containing 2-8 million cells), and inject the cells into brain around the site damaged by the stroke
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
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects can be of either gender and must be between 35 through 75 years of age.
- •Subjects must have had ischemic stroke more than 6 and less than 60 months ago.
- •Subjects must have stable hemiplegia or hemiparesis condition at least for 3 months.
- •Subjects must have stroke-induced clinical deficits affecting motor, perceptual, or language functions, with a National Institutes of Health Stroke Scale (NIHSS) of 5-
- •Subjects must have stroke in the middle cerebral artery territory.
- •Subjects must have an available umbilical cord blood unit that has an HLA-match of at least 5:6 (HLA-A, -B, and -DR).
- •Subjects must be able to read and understand the informed consent form that has been approved by the appropriate Institutional Review Board (IRB). The subject must sign and date the informed consent form before any study-specific procedures. (Note: If a subject consents to participation but is not in a position to sign and date the informed consent form personally because of his or her physical conditions, the consent form must be confirmed orally at the time of consent, marked or finger printed by the subject voluntarily). The informed consent procedure must be observed by an independent witness who is present throughout the whole informed consent process and sign the consent form.
排除标准
- •Subject has evidence of a non-ischemic mechanism, subarachnoid hemorrhage, primary intracerebral or intraventricular hemorrhage or MRI has shown that the occlusion is not in the middle cerebral artery territory.
- •Pregnant or lactating women.
- •History of alcohol or drug abuse in the previous 3 months.
- •Subjects must not have the following conditions in documents:
- •significant renal, cardiovascular, hepatic, or psychiatric disease
- •abnormal blood coagulation parameters,
- •immunodeficiency (e.g. AIDS)
- •tumors, leukemia, and other cancer that may interfere with the clinical trial protocol
- •infectious diseases, including hepatitis, or other conditions that may be a contraindication to the planned therapies and evaluation.
- •Subject must not be currently participating in another investigational study or taking any investigational drug within the last four weeks before the screening of this study.
- •Any other condition that, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol and would not be suitable to perform a surgery or to participate in the study.
结局指标
主要结局
Change from Baseline in NIH Stroke Scale(NIHSS)
时间窗: Change from Baseline in NIHSS at 2 weeks
Evaluate change from Baseline in NIHSS at 2 weeks
Change from baseline in NIH Stroke Scale (NIHSS)
时间窗: Change from baseline in NIHSS at 1 weeks
Evaluate change from Baseline in NIHSS at 1 week
Change from baseline in NIH Stroke Scale
时间窗: Change from baseline in NIHSS at 4 weeks
Evaluate change from baseline in NIHSS at 4 weeks
Change from baseline in NIH Stroke Scale ( NIHSS)
时间窗: Change from baseline in NIHSS at 12 weeks
Evaluate change from baseline in NIHSS at 12 weeks
次要结局
- Change from baseline in Brain Image(Change from baseline in Brain Image at 6 months)
研究者
Shinn-Zong Lin
Professor of Neurosurgery, China Medical University
China Medical University Hospital