A Phase I/II Safety and Tolerability Study Following the Autologous Infusion of Immuno-selected CD34+ Subset Bone Marrow Stem Cells Into Patients With Acute Total Anterior Circulation Ischaemic Stroke
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Safety will be evaluated in terms of adverse events graded according to CTC toxicity criteria and laboratory test results
研究概览
简要总结
The aim of the study is to determine the safety and tolerability of an autologous CD34+ subset bone marrow stem cell infusion into the middle cerebral artery in patients who have suffered acute total or partial anterior circulation syndrome (TACS/PACS).
详细描述
The proposed trial will involve the recruitment of a total of 10 patients.
The cells will be collected from each subject recruited, via bone marrow sampling. CD34+ stem cells will then be isolated and harvested during a process of immuno-selection in accordance with the principles of Good Manufacturing Practice. The CD34+ cells will then be directly infused into the area of the stroke intra-arterially using the middle cerebral artery.
Initially, the investigator will monitor each patient for a period of 6 months post-stem cell infusion. Thereafter, they will revert to their previous treatment regime in the clinic.
Assessment of adverse events will be by physical examination and measurement of laboratory parameters. Assessment of efficacy will be by physical examination and the measurement of laboratory, CT and MRI parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms and signs of clinically definite acute stroke
- •Time of stroke onset is known and treatment can be started within 7 days of onset
- •CT or MRI brain scanning has reliably excluded both intracranial haemorrhage and structural brain lesions which can mimic stroke (e.g. cerebral tumour)
- •The stroke is severe and conforming to the TACS phenotype (weakness, homonymous hemianopia and a focal cognitive deficit (e.g. aphasia) or reduction in consciousness) or PACS phenotype (two out of the three TACS criteria)
- •An age range of 30-80 years old
- •Stroke confined to MCA territory on CT or MRI brain imaging
- •NIHSS score >/= 8
排除标准
- •Known defect of clotting or platelet function (but patients on anti-platelet agents can enrol)
- •Haematological causes of stroke
- •Severe co-morbidity
- •Hepatic or renal dysfunction
- •The patient is female and of childbearing potential (unless it is certain that pregnancy is not possible) or breast feeding
- •Hypo- or hyperglycaemia sufficient to account for the neurological symptoms; the patient should be excluded if their blood glucose is < 3.0 or > 20.0mmol/L
- •Patient is likely to be unavailable for follow-up e.g. no fixed home address
- •Patients with evidence of life threatening infection (e.g. HIV) or life threatening illness (e.g. advanced cancer)
- •Patient was already dependent in activities of daily living before the present acute stroke
- •Patients who have been included in any other clinical trial within the previous month
研究组 & 干预措施
CD34+ stem/progenitor cell therapy
Patients presenting within 7 days of onset with severe anterior circulation ischemic stroke (National Institutes of Health Stroke Scale [NIHSS] score≥8). CD34+ cells were collected from the bone marrow of the subjects before being delivered by catheter angiography into the ipsilesional middle cerebral artery.
干预措施: Infusion of autologous CD34+ stem cells into middle cerebral artery (Biological)
结局指标
主要结局
Safety will be evaluated in terms of adverse events graded according to CTC toxicity criteria and laboratory test results
时间窗: Duration of study
safety will be evaluated in terms of adverse events graded according to CTC toxicity criteria and laboratory test results
次要结局
- Improvement in clinical function as assessed by the Modified Rankin Score, and NIH stroke scale.(Duration of study)