Steered t-PA Delivery for Thrombolysis Test Using Magnetic Swarming Nanorobots on Human Placenta as an ex Vivo Model of Human Cerebral Vascular System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Time for recanalization
研究概览
简要总结
Tissue plasminogen activator (tPA) is the FDA approved thrombolytic drug for patients with acute ischemic stroke. While transcatheter endovascular therapy is widely accepted as an effective method for targeted blood vessels via a catheter to elicit ischemic necrosis.
To improve targeting accuracy administrated tPA and avoiding collateral tissue damage, we developed a magnetic nanorobotic system to active system to active intravenous delivery of tPA for targeted thrombus removal. Here human placenta will be used as an ex vivo model for human cerebral vascular system in our ex vivo thrombolysis study. Our magnetic nanorobotic system encapsulated with tPA overcomes the limitations of passive thrombolytic therapy with tPA alone and will be a promising approach for the treatment of ischemic stroke and other thrombotic diseases
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy pregnant women at 20-45 years of age of any ethic origin, giving childbirth with natural delivery or caesarean sections after 37-42 weeks of gestation.
- •Healthy singleton pregnancy.
- •Participant able to give voluntary, written, informed consent to participate in the study.
排除标准
- •Abnormal prenatal development (e.g intrauterine growth restriction)
- •Early preterm birth < 37 weeks
- •Verbal Confirmation of hypercholesterolemia
- •Family history of stroke or vascular disease
- •Type I or Type II diabetes and gestational diabetes
- •Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative.
- •Clinically significant abnormal laboratory results at screening.
- •Any other active or unstable medical condition.
- •History of liver disease.
- •History of hypertension (including pre-eclampsia)
结局指标
主要结局
Time for recanalization
时间窗: 1 -2 hours
Time for recanalization of occluded vessels, mins
Thrombolysis performance
时间窗: 1 -2 hours
Size of thrombus by angiography, mm
Damage to vessels
时间窗: 1 -2 hours
Histological damage evaluation. The vessels are sectioned and stained with H\&E stain
次要结局
- Distribution of administrated nanorobots(1 - 2 hours)
- Dosage requirement(1 - 2 hours)
- Stability of magnetic nanorobots(1 - 2 hours)
研究者
ZHANG Li
Professor
Chinese University of Hong Kong