NCT01461720Unknown2 期
An Open Lable, Phase II Exploratory Study Assessing the Efficacy of Intravenous Autologous Mesenchymal Stem Cells in Patients With Middle Cerebral Artery Infarct
National University of Malaysia2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年3月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in NIH Stroke Scale
研究概览
简要总结
This study aims to determine the efficacy of intravenous transplantation of autologous bone marrow-derived mesenchymal stem cells in patients with acute middle cerebral artery infarct.
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Experiences stroke onset within 2 weeks to 2 months
- •NIHSS score of >10-35
- •Never received or failed thrombolysis
- •Evidence of unilateral middle cerebral artery infarct on brain MRI
排除标准
- •Medically unfit (eg. those are unstable haemodynamically despite treatment, with worsening conscious level and with other serious medical co-morbidity)
- •Evidence of any tumor or other space-occupying lesion on brain MRI
- •Evidence of hemorrhagic stroke on brain CT or MRI
- •Experiences transient ischemic attack or lacunar infarct
- •Has any acute or chronic infections such as Hepatitis B, Hepatitis C and HIV
- •Is diagnosed with concurrent malignancy or primary hematological disorders
- •Renal impairment indicated with serum creatinine greater than 200 umol/l or creatinine clearance less than 30 ml/min
- •Liver impairment indicated with serum aspartate transaminase and serum alanine transaminase greater than 4 times upper limit of the normal range
- •Any contraindication to stem cell transplantation or bone marrow biopsy
- •Any co-morbidity which will compromise the ability to obtain adequate stem cells (eg. chronic debilitating diseases, frail patients and patients with known osteoporosis)
- •Any contraindication to brain MRI (eg. metal implants, pacemaker, joint implants and ocular implants)
结局指标
主要结局
Change in NIH Stroke Scale
时间窗: 1 year
Change in Barthel Index
时间窗: 1 year
Change in modified Rankin Scale
时间窗: 1 year
Change in size of infarct based on brain MRI stroke sequences
时间窗: 1 year
次要结局
- Change in Stroke Specific Quality of Life Scale(1 year)
- Change in Stroke Impact Scale(1 year)
研究者
Dr Norlinah Mohamed Ibrahim
Consultant Neurologist
National University of Malaysia
研究点 (2)
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