此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Study of Purified Umbilical Cord Blood CD34+ Stem Cell on Chronic Ischemic Stroke

2012年7月31日 更新者:Shinn-Zong Lin、China Medical University Hospital

An Exploratory Clinical Trial to Assess Treatment of Chronic Ischemic Stroke With Brain Transplants of Purified CD34+ Umbilical Cord Blood Stem Cells

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.

研究概览

详细说明

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

研究类型

介入性

注册 (预期的)

6

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Taichung、台湾、244
        • China Medical University Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

35年 至 70年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Subjects can be of either gender and must be between 35 through 75 years of age.
  2. Subjects must have had ischemic stroke more than 6 and less than 60 months ago.
  3. Subjects must have stable hemiplegia or hemiparesis condition at least for 3 months.
  4. Subjects must have stroke-induced clinical deficits affecting motor, perceptual, or language functions, with a National Institutes of Health Stroke Scale (NIHSS) of 5-15.
  5. Subjects must have stroke in the middle cerebral artery territory.
  6. Subjects must have an available umbilical cord blood unit that has an HLA-match of at least 5:6 (HLA-A, -B, and -DR).
  7. 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.

Exclusion Criteria:

  1. 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.
  2. Pregnant or lactating women.
  3. History of alcohol or drug abuse in the previous 3 months.
  4. 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.
  5. 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.
  6. 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:HUCB, Medicine, Rehabilitation
Stroke patients are received intracerebral implantation of human cord blood stem cells (CD34+), Antiplatelet Medication, and Rehabilitation.
Each patient will receive brain implant of approximately 5 million allogenic Umbilical cord blood CD34+ Stem Cell
其他名称:
  • 造血干细胞
  • Cord Blood Stem Cell
  • UCB Stem Cell

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change from baseline in NIH Stroke Scale (NIHSS)
大体时间:Change from baseline in NIHSS at 1 weeks
Evaluate change from Baseline in NIHSS at 1 week
Change from baseline in NIHSS at 1 weeks
Change from Baseline in NIH Stroke Scale(NIHSS)
大体时间:Change from Baseline in NIHSS at 2 weeks
Evaluate change from Baseline in NIHSS at 2 weeks
Change from Baseline in NIHSS at 2 weeks
Change from baseline in NIH Stroke Scale
大体时间:Change from baseline in NIHSS at 4 weeks
Evaluate change from baseline in NIHSS at 4 weeks
Change from baseline in NIHSS at 4 weeks
Change from baseline in NIH Stroke Scale ( NIHSS)
大体时间:Change from baseline in NIHSS at 12 weeks
Evaluate change from baseline in NIHSS at 12 weeks
Change from baseline in NIHSS at 12 weeks

次要结果测量

结果测量
措施说明
大体时间
Change from baseline in Brain Image
大体时间:Change from baseline in Brain Image at 1 week
Brain Image will be performed by MRI. The MRI evaluation includes DEI, T1W, T2W, MRS, and DTI, and change from baseline will be evaluated at 1 week
Change from baseline in Brain Image at 1 week
Change from baseline in Brain Image
大体时间:Change from baseline in Brain Image at 4 weeks
Brain Image will be performed by MRI. The MRI evaluation includes DEI,T1W,T2W,MRS and DTI , and evaluate the change from baseline at 4 weeks
Change from baseline in Brain Image at 4 weeks
Change from baseline in Brain Image
大体时间:Change from baseline in Brain Image at 6 months
Brain Image will be performed by MRI.MRI image includes DEI,T1W, T2W, and DTI, and change from baseline will be evaluated at 6 months.
Change from baseline in Brain Image at 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Shinn-Zong Lin, M.D.;PhD.、China Medical University Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年1月1日

初级完成 (预期的)

2013年12月1日

研究完成 (预期的)

2013年12月1日

研究注册日期

首次提交

2011年9月7日

首先提交符合 QC 标准的

2011年9月21日

首次发布 (估计)

2011年9月22日

研究记录更新

最后更新发布 (估计)

2012年8月2日

上次提交的符合 QC 标准的更新

2012年7月31日

最后验证

2011年12月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅