Ex Vivo Test of New Stroke Treatment Using Magnetic Nanorobots

Recruiting

• Conditions: Thrombosis

• Registration Number: NCT04644653
• Lead Sponsor: Chinese University of Hong Kong

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2020-11-19
• Study First Submitted QC: 2020-11-20
• Study First Posted: 2020-11-25
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-09
• Last Update Posted: 2022-03-24
• Primary Completion: 2025-08-31
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Distribution of administrated nanorobots	1 - 2 hours	The distribution of administrated nanorobots. The position of nanorobots is tracked by MRI.
Dosage requirement	1 - 2 hours	Dosage requirement of nanorobots and thus t-PA, mg
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.

Trial Locations

Locations (2)

Advanced Nanomaterials & Microrobotics Laboratory, Room 202, William M.W Mong Engineering Building, CUHK and Room 508, Li Ka Shing Medical Sciences Building, Prince of Wales Hospital; 🇭🇰 Shatin, New Territories, Hong Kong

Department of Obstetrics and Gynaecology, Prince of Wales Hospital; 🇭🇰 Shatin, New Territories, Hong Kong