Ex Vivo Test of New Stroke Treatment Using Magnetic Nanorobots

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04644653

Enrollment

100

Registered

2020-11-25

Start date

2020-09-01

Completion date

2025-09-30

Last updated

2022-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombosis

Brief summary

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

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Secondary

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

Countries

Hong Kong

Outcome results