Ex Vivo Test of New Stroke Treatment Using Magnetic Nanorobots

Study Overview
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Brief Summary
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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

Official Title
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Steered t-PA Delivery for Thrombolysis Test Using Magnetic Swarming Nanorobots on Human Placenta as an ex Vivo Model of Human Cerebral Vascular System

Conditions
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Thrombosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombolysis performance | Size of thrombus by angiography, mm | 1 -2 hours | 
| Time for recanalization | Time for recanalization of occluded vessels, mins | 1 -2 hours | 
| Damage to vessels | Histological damage evaluation. The vessels are sectioned and stained with H&E stain | 1 -2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stability of magnetic nanorobots | Controllability of the magnetic nanorobots. The loss in mass of nanorobots after magetic navigation in blood vessels is measured. | 1 - 2 hours | 
| Dosage requirement | Dosage requirement of nanorobots and thus t-PA, mg | 1 - 2 hours | 
| Distribution of administrated nanorobots | The distribution of administrated nanorobots. The position of nanorobots is tracked by MRI. | 1 - 2 hours |