NCT01649700已完成1 期
Treatment of Sequelae Caused by Severe Brain Injury With Autologous Adipose-derived Mesenchymal Stem Cells
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Safety evaluation
研究概览
简要总结
The study is to investigate the efficacy and safety of autologous transplantation of adipose-derived mesenchymal stem cells in patients with the sequelae caused by severe brain injury.
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
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a confirmed diagnosis of a brain AVM (arteriovenous malformation).
- •Stroke-like symptoms, including paralysis, caused by brain AVM hemorrhage.
- •Subject's modified Rankin scale (mRS) grades IV~V.
- •Ages between 20~40 years.
- •Estimated life expectancy must be greater than 2 months.
- •Signed informed consent from the subject.
排除标准
- •Pregnancy test positive.
- •Subject infected with hepatitis C, HIV or syphilis.
- •Subject not suitable for liposuction surgery.
- •Subject not eligible for PET or MRI.
- •Subject enrolled in any other cell therapy studies within the past 30 days.
- •Subject deemed to be not suitable for the study by the investigator.
结局指标
主要结局
Safety evaluation
时间窗: 16 months
Safety evaluate through vital signs, the results of clinical lab tests and adverse events (AEs).
次要结局
- Positron emission tomography(13 months)
- Magnetic Resonance Imaging(16 months)
- Electroencephalogram(16 months)
- Neuropsychological assessment(16 months)
- Electrodiagnostic Testing(16 months)
- Assessment of language and swallowing functions(16 months)
- Measure of the severity of disability(16 months)
- Assessment of brain motor control(16 months)
- Assessment of spasticity and strength(16 months)
研究者
Oscar Kuang-Sheng Lee
Director of Stem Cell Research Centre
National Yang Ming Chiao Tung University
研究点 (1)
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