Safety and Feasibility Study of Umbilical Cord Blood Mononuclear Cells Transplant to Treat Ischemic Stroke
Phase 1 Clinical Trial to Establish the Safety and Feasibility of Transplants of Umbilical Cord Blood Mononuclear Cells in Chronic Ischemic Stroke
研究概览
详细说明
This is an open-label, delayed-treatment trial.
A total of 12 subjects fulfill the inclusion and exclusion criteria will be recruited and randomly assigned into two treatment group. Group A (early-treatment group) will receive transplant of UCBMC isolated from HLA-matched umbilical cord blood at Day 0. Group B (delayed-treatment group) will participate in 6 months observation before the UCBMC transplantation at Month 6. All subjects will be followed up for 18 months from enrollment at Day 0. Long-term follow-up will be carried up to 36 months if applicable.
The adverse events and safety parameters will be collected and recorded. In addition, the stroke scores , gait and brain MRI will be obtained before and after the treatment to assess the safety and potential treatment effect of UCBMC in chronic ischemic stroke.
研究类型
注册 (预期的)
阶段
- 阶段1
联系人和位置
学习地点
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Hong Kong、香港
- 招聘中
- Queen Mary Hospital
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接触:
- Karrie Kiang
- 电话号码:+852 2255 4468
- 邮箱:mykiang@hku.hk
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首席研究员:
- Gilberto Ka Kit Leung, MD
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Shatin、香港
- 招聘中
- Prince of Wales Hospital
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接触:
- Waisang Poon, MD
- 电话号码:+852 2632 1625
- 邮箱:stroke-study@surgery.cuhk.edu.hk
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首席研究员:
- Waisang Poon, MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- either gender, age 35 -65 years old;
- ischemic stroke > 6 months and < 60 months;
- stable hemiplegia or hemiparesis condition > 3 months;
- stroke-induced clinical deficits affecting motor, perceptual, or language functions, with NIHSS of 5-15;
- stroke in the middle cerebral artery territory;
- subjects able to understand, sign and date the informed consent form
Exclusion Criteria:
- non-ischemic mechanism, subarachnoid hemorrhage, primary intracerebral or intraventricular hemorrhage;
- pregnant or lactating women;
- alcohol or drug abuse in previous 3 months;
- significant medical diseases or infections;
- current participation in another investigational study or taking any investigational drug within last 4 weeks before the screening;
- unavailability of HLA-matched umbilical cord blood unit;
- investigator suggests that the subject would not suitable to perform the surgery or participate in the study
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 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:Group A - UCBMC Early Treatment Group
Group A subjects will receive transplant of UCBMC isolated from HLA-matched umbilical cord blood at Day 0.
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Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site
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实验性的:Group B - UCBMC Delayed Treatment Group
Group B subject will partipate in 6 months observation and then receive the UCBMC transplant at month 6.
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Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site
|
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 |
---|---|---|
National Institutes of Health Stroke Scale
大体时间:18 months, up to 36 months
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The change from the baseline in National Institutes of Health Stroke Scales
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18 months, up to 36 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
European Stroke Scale (ESS)
大体时间:18 months, up to 36 months if applicable
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The change from baseline in ESS
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18 months, up to 36 months if applicable
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Barthel Index
大体时间:18 months
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18 months
|
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Min-Mental State Examination (MMSE)
大体时间:18 months
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The change from baseline in MMSE
|
18 months
|
MRI
大体时间:18 months
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The change in MRI between pre-treatment and post-treatment
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18 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Safety as assessed by the incidence and severity of adverse events, clinically-significant changes in lab tests, vital signs, physical and neurological examinations.
大体时间:18 months, up to 36 months follow-up
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Safety are assessed by the incidence and severity of adverse events, clinically-significant changes in lab tests, vital signs, physical and neurological examinations.
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18 months, up to 36 months follow-up
|
合作者和调查者
合作者
调查人员
- 首席研究员:Waisang Poon, MD、The Chinese University of Hong Kong, Prince of Wales Hospital
- 首席研究员:Gilberto Ka Kit Leung, MD、The University of Hong Kong, Queen Mary Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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外科手术的临床试验
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St. Joseph's Healthcare HamiltonHamilton Academic Health Sciences Organization完全的
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Seoul National University HospitalJohnson & Johnson Medical Companies完全的