Phase I Study of Autologous Bone Marrow Cell Transplantation in Patient With Ischemic Stroke
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Absence of new neurological deficits during the procedure and/or in the 4 months follow-up.
研究概览
简要总结
This is a open label study to assess the safety of autologous bone marrow transplantation in patients with a ischemic stroke in the middle cerebral artery territory within 90 days from symptoms onset.
详细描述
Objective
The purpose of this study is to evaluate the safety and feasibility of intra-arterial and intravenous injection of autologous bone marrow mononuclear cells in patients in the acute and sub-acute phase (> 3 and < 90 days after symptoms onset) of ischemic cerebral infarct in the middle cerebral artery territory.
Methods: 15 patients with cerebral infarct within the middle cerebral artery territory will be enrolled in this prospective, nonrandomized, open-labeled study. Up to 10 patients will receive up to 500x 10 6 autologous bone marrow cells injected intra-arterially into the middle cerebral artery through percutaneous approach. The procedure is monitored by Transcranial Doppler (TCD) and electroencephalogram (EEG). Other 5 patients will receive up to 500x 10 6 autologous bone marrow cells injected intravenously. Changes in neurological deficits and improvements in functions will be evaluated at baseline and at regular intervals during follow-up ( 4 months). EEG and neuroimaging exams will be performed at baseline and at regular intervals during the follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of ischemic stroke lasting for more than 3 hours and less than 90 days from symptoms onset
- •neuroimages exams showing ischemic cerebral infarct in the middle cerebral artery territory
- •age between 18 and 75 years old
- •NIHSS between 4 and 20
- •spontaneous re-canalization of the middle cerebral artery documented by TCD or MRI
- •signed informed consent
排除标准
- •difficult in obtaining vascular access for percutaneous procedures
- •vascular impossibility to reach the middle cerebral artery through percutaneous approach
- •severe carotid stenosis( >70%, by Doppler) related to the severe stroke
- •neurological worsening (>4 points in the NIHSS ) due to edema or intracerebral hemorrhage
- •primary hematological disease
- •neurodegenerative disorder
- •previous stroke with mRS > 2
- •intracardiac thrombosis
- •auto-imune disorders
- •osteopathies that could increase the risk of bone marrow harvesting procedure
- •thrombophilias
- •liver failure
- •chronic renal failure (creatinine > 2mg/ml)
- •life support dependence
- •lacunar stroke
- •pregnancy
- •history of neoplasia or other comorbidity that could impact patient's short-term survival
- •any condition that in the judgment of the investigator would place the patient under undue risk
结局指标
主要结局
Absence of new neurological deficits during the procedure and/or in the 4 months follow-up.
时间窗: 4 months
次要结局
- Improvement of neurological deficits(4 months)
- Improvement in the neuroimaging exams(4 months)