Adipose-Derived Stem Cells (ADSCs) Injections for Stroke
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Neurological function
研究概览
简要总结
The objective of the study is to confirm the safety and possible efficacy of Adipose-Tissue Derived Stem Cells treatment of chronic stroke. Specifically, the study will transplant autologous ADSCs into brain surrounding ischemic infarct in adult (65-80 years old) subjects who have chronic non-hemorrhagic stroke (>6 months).
详细描述
This open-label clinical trial will compare outcomes of subjects with chronic stroke. Six subjects will be to treatment (n=3) groups. The treatment group will receive brain transplants of autologous ADSCs. Treatment group will receive rehabilitation after the transplantation. Subjects will be assessed by magnetic resonance imaging (MRI) and eight standardized stroke indices: National Institutes of Health Stroke Scale (NIHSS), ( Barthel Index )、 ( Berg balance scale )、 (Fugl - Meyer test )、(Action research arm test )、 (Purdue pegboard )、 ( grip strength measurement ) 、(somatosensory evoked potential, SSEP) at 1 month, 3 months, and 6 months after treatment.
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
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stroke investigators with age 65 to 80 years
- •history of stroke between six months and 10 years
- •Systolic pressure and Diastolic pressure were maintained under 160 mmHg and 110 mmHg
- •INR < 2.5, platelets counts 1-5 x 10^5/μl
- •Damaged area range between 0.5 cm to 6 cm by brain MRI
排除标准
- •Pregnant women
- •Investigators with AIDS, cancer, liver dysfunction
- •Others can't fit into the trial evaluate by investigator
研究组 & 干预措施
GXNPC1
Three subjects will be to treatment (n=3) groups. The treatment group will receive brain transplants of autologous ADSCs. Treatment group will receive rehabilitation after the transplantation. Subjects will be assessed by magnetic resonance imaging (MRI) and four standardized stroke indices: National Institutes of Health Stroke Scale (NIHSS), European Stroke Scale (ESS), European Stroke Motor Subscale (EMS), Barthel Index, MMSE and Gait analyses at 1 month, 3 months, and 6 months after treatment.
干预措施: ADSCs (Drug)
结局指标
主要结局
Neurological function
时间窗: 6 months
Blood biochemical, Neurobehavioral examination (NIH Stroke Scale 16-20)
次要结局
未报告次要终点