Intra-arterial Autologous Bone-marrow Mononuclear Cells Infusion for Acute Ischemic Stroke. A Phase II, Open-label, Multicenter, Randomized and Controlled Clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 4
- 主要终点
- Disability
研究概览
简要总结
This trial aims to test that intra-arterial injection of autologous bone marrow mononuclear cells in acute ischemic stroke patients is safe and improves neurological outcomes.
详细描述
This is a study in which the patients will be included diagnosed of ischemic stroke sharply in the territory of the cerebral average artery that there fulfill criteria of incorporation and none of those of exclusion and that they have signed the informed assent. 76 patients will randomize in proportion 2:1:1 in a group control that will receive only medical conventional treatment and in two groups of intervention that will receive an unique intra-arterial infusion of mononuclear autologous bone marrow stem cells (one group of dose of 2 millions of BMSC for kilogram of weight and another group of dose of 5 millions of BMSC for kilogram of weight). The three groups of patients will be followed for 24 months. The randomization will be stratified depending on the NHSS score. This clinical trial has a voluntary substudy to obtain information on plasma biomarkers.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with middle cerebral artery (MCA) acute ischemic stroke.
- •Time of stroke onset is known and treatment can be started between day 1 and 7 of onset.
- •DWI-MRI has reliably shown acute MCA ischemic lesions
- •Magnetic resonance angiography (MRA) must confirm ipsilateral MCA permeability
- •National Institute of Health Stroke Scale score of 6-20 at inclusion
- •Age 18-80 years
- •Written informed consent has been obtained
排除标准
- •Hemorrhagic stroke or symptomatic hemorrhagic transformation
- •Lacunar infarction
- •Preocclusive stenosis or total occlusion of ipsilateral carotid artery
- •Worsening of ≥4 points in National Institute of Health Stroke Scale in the 24 hours previous to inclusion, attributable to edema or hemorrhagic transformation or suspicious of malignant edema
- •Decrease of consciousness with a Glasgow Coma Scale of <8 points
- •Patients with present or previous malignant disease during the last 5 years, except for basal cell carcinoma
- •Contraindication for MRI or for bone marrow harvest
- •Previous diagnosis of neurodegenerative disease
- •Acute heart failure
- •Hepatic or renal dysfunction (creatinine >2mg/dL)
- •Coagulopathy
- •Severe co-morbidity
- •Pregnancy, childbearing potential (unless it is certain that pregnancy is not possible) or breast feeding
- •Modified Rankin Score (mRS) before stroke of ≥2
- •Participation in any clinical trial in the last 3 months
研究组 & 干预措施
Bone marrow transplantation low dose
Intra-arterial autologous bone marrow mononuclear cells injection (dose 2x10^6 per kilogram)
干预措施: Autologous bone marrow mononuclear cell intra-arterial injection (Drug)
Bone marrow transplantation high dose
Intra-arterial autologous bone marrow mononuclear cells injection (dose 5x10^6 per kilogram)
干预措施: Autologous bone marrow mononuclear cell intra-arterial injection (Drug)
结局指标
主要结局
Disability
时间窗: 6 months
Proportion of patients with modified Rankin Scale scores of 0-2 at 6 months
次要结局
- Mortality(24 months)
研究者
Francisco Moniche
Neurologist
Hospitales Universitarios Virgen del Rocío