Study the Safety and Efficacy of Human Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Acute Cerebral Infarction
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
- Treatment related-adverse events counting
研究概览
简要总结
The purposes of the study is to determine the safety and efficacy of treating acute ischemic stroke patients with human umbilical cord mesenchymal stem cells (hUC-MSC).
详细描述
This is a randomized, double-blind, paralleled study. 40 patients will be separated into two groups, and receive basic treatment (Aspirin Tablet). Patients in experimental group will receive hUC-MSC once a month, total 3 times. After the treatment, investigator will have follow-up visit for 6 months, evaluate the security and efficacy of hUC-MSC.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient within 2 weeks onset of symptoms.
- •Symptoms and signs of clinically definite acute cerebral infarction patients.
- •CT/MRI prove the Oxfordshire Community Stroke Project (OCSP) as Total Anterior circulation infarct (TACI), Partial Anterior circulation infarct (PACI), Posterior Anterior circulation infarct (POCI), or obvious neurological deficit lacunar infarction patient.
- •Signed informed consent after understanding all possible benefits and harm.
排除标准
- •allergic to basic drug
- •with progressive stroke, transient ischemia attach, cerebral infarction with posterior cerebral hemorrhage, and cerebral arteritis.
- •tumor, injury, and parasites caused cerebral embolism
- •rheumatic heart disease, coronary heart disease, and other atrial fibrillation combined heart disease caused cerebral embolism
- •subject is processing thrombolytic therapy
- •subject is pregnancy and of childbearing potential or breast feeding
- •participate in any other clinical trial in last 3 months
- •bleeding tendency patient; severe bleeding tendency in last 3 month
- •with gastric duodenal ulcer
- •participants with severe liver and kidney, hematopoietic, and metabolic diseases; Or with liver and kidney function examination abnormal
- •participants are intolerance with Aspirin Enteric-coated Tablets, or need other antiplatelet drugs
- •participants: alcoholism, drug addicted, or other situations may complicated the results
- •under other therapy that possibly influence MSC security or efficacy
- •investigator supposes not suitable to participate this clinical trail
研究组 & 干预措施
Group 1
Aspirin Tablet, 100mg/d; Allogeneic umbilical cord mesenchymal stem cells, 0.5-1*10^6/kg
干预措施: Aspirin Tablet (Drug)
Group 1
Aspirin Tablet, 100mg/d; Allogeneic umbilical cord mesenchymal stem cells, 0.5-1*10^6/kg
干预措施: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) (Biological)
Group 2
Aspirin Tablet, 100mg/d; Placebo
干预措施: Aspirin Tablet (Drug)
结局指标
主要结局
Treatment related-adverse events counting
时间窗: 26 weeks
patients will be monitored for any adverse events resulting from the treatment of Human Umbilical Cord Mesenchymal Stem Cells
次要结局
- NIH stroke scale (NIHSS)(26 weeks)
- Modified Rankin Scale(26 weeks)
- Barthel activities of daily living (ADL) Index(26 weeks)