The Effects of Human Umbilical Cord Mesenchymal Stem Cell Therapy on Neurological Function for Cerebral Infarction Patients in Convalescent Period.
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Motor function analysis
研究概览
简要总结
This is a randomized, double-blind study. Human umbilical cord mesenchymal stem cells (hUC-MSC) will be treated on cerebral infarction patients, and evaluates their neurological function of convalescent period.
详细描述
40 participants will be selected based on eligibility criteria and collected information, then, randomly separated into two groups. All participants will sign informed consent form, monitor vital signs, laboratory examination (CT/MRI, blood routine examination, urine routine examination, liver function, renal function, etc.), NIHSS, Fugl-Meyer analysis (FMA) 0-3 days before treatment. All of them will receive basic treatment with Aspirin Enteric-coated Tablets and Atorvastatin Calcium. And experimental group will treat with hUC-MSC, control group with placebo (normal saline) on the 7th and 14th day. After the treatment, investigator will follow-up, monitor vital signs, laboratory examination, NIHSS, FMA analysis on 2 weeks, 1 month, and 6 months after the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •proved cerebral infarction by CT or MRI.
- •no cerebrovascular disease before
- •signed informed consent form
排除标准
- •serious body and intracranial lesions (tumor, infection, etc.)
- •patients repeated cerebral infarction attacks
- •multi-foci of cerebral infarction
- •history of drug dependence and mental disease
- •disturbance of consciousness and non-compliance patients
- •subjects who are HIV positive
- •pregnant or lactation
- •donor: HIV infected, Active hepatitis B/C infected, Syphilis antibody positive
- •subjects/ donor: alcoholism, drug addicts or mental disease
研究组 & 干预措施
Experimental group
Basic medication：Aspirin Enteric-coated Tablets & Atorvastatin Calcium； Allogeneic umbilical cord mesenchymal stem cells
干预措施: Allogeneic umbilical cord mesenchymal stem cell (Biological)
Experimental group
Basic medication：Aspirin Enteric-coated Tablets & Atorvastatin Calcium； Allogeneic umbilical cord mesenchymal stem cells
干预措施: Aspirin Enteric-coated Tablets & Atorvastatin Calcium (Drug)
Control group
Basic medication：Aspirin Enteric-coated Tablets & Atorvastatin Calcium; Placebo：saline
干预措施: Aspirin Enteric-coated Tablets & Atorvastatin Calcium (Drug)
结局指标
主要结局
Motor function analysis
时间窗: 6 months
Based on Activity of Daily Living Scale (ADL) to analysis efficacy of cell treatment.The score of patient with upper limb \>60, and total score \>90 is considered good recovery.
次要结局
- Limb motor function analysis(6 months)
- Barthel Index analysis(6 months)
- Neurological deficits analysis(6 months)