Safety and Efficacy of Allogenic Mesenchymal Stem Cells Derived Exosome on Disability of Patients With Acute Ischemic Stroke: a Randomized, Single-blind, Placebo-controlled, Phase 1, 2 Trial
试验速览
- 阶段
- 1 期
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
Administration of cell-free exosomes derived from mesenchymal stem cell (MSCs) can be sufficient to exert therapeutic effects of intact MSCs after brain injury. In this study we aim to assay the administration of MSC derived exosome on improvement of disability of patients with acute ischemic stroke
详细描述
Exosomes derived from multipotent mesenchymal stromal cells (MSCs) promote neurovascular remodeling and functional recovery after stroke. Animal study has shown that Exosome treatment markedly increased the number of newly formed doublecortin (a marker of neuroblasts) and von Willebrand factor (a marker of endothelial cells) cells. Based on previous literature, intravenous administration of MSC-generated exosomes post stroke improves functional recovery and enhances neurite remodeling, neurogenesis, and angiogenesis and represents a novel treatment for stroke. Also some studies have presented which miR-124-Loaded Exosomes ameliorate the brain Injury by promoting neurogenesis. So in present study we aim to assess improving patients with acute ischemic stroke who received MSC derived exosome
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female acute ischemic patients aged 40-80 years with symptoms of acute cerebral infarction of less than 24h from stroke onset.
- •Patients with infarct size 3*3
- •Patients with a measurable focal neurological that must persist to the time of treatment without clinically meaningful improvement.
- •Patients must have computerized tomography (CT) and / or magnetic resonance imaging (MRI) compatible with the clinical diagnosis of acute ischemic stroke in the territory of the middle cerebral artery before being included in the study.
- •Patients must have a score on the NIH Stroke Scale 8-24, and mRS ≤ 1
- •Women of childbearing age should have a negative pregnancy test performed prior to inclusion
- •Obtaining informed consent signed
排除标准
- •Comatose patients.
- •brain tumour, cerebral oedema with compression of ventricles, cerebellar infarction or brainstem, or intraventricular, intracerebral or subarachnoid haemorrhage.
- •alcohol use Active infectious disease, including HIV, hepatitis B, Hepatitis .
- •patients with dementia.
- •Specify clinical conditions
- •Patients who are participating in another clinical trial.
- •Inability or unwillingness of individual for giving written informed consent.
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: 12 months
deteriorating stroke, stroke recurrences, brain oedema, seizures, hemorrhagic transformation
次要结局
- measurement of Modified Ranking Scale(12 months)
研究者
Leila Dehghani
Dr Masoud Soleimani
Isfahan University of Medical Sciences