Ex Vivo Test of New Stroke Treatment Using Magnetic Nanorobots

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT04644653
Collaborator
(none)
100
2
60.9
50
0.8

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Steered t-PA Delivery for Thrombolysis Test Using Magnetic Swarming Nanorobots on Human Placenta as an ex Vivo Model of Human Cerebral Vascular System
    Actual Study Start Date :
    Sep 1, 2020
    Anticipated Primary Completion Date :
    Aug 31, 2025
    Anticipated Study Completion Date :
    Sep 30, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Thrombolysis performance [1 -2 hours]

      Size of thrombus by angiography, mm

    2. Time for recanalization [1 -2 hours]

      Time for recanalization of occluded vessels, mins

    3. Damage to vessels [1 -2 hours]

      Histological damage evaluation. The vessels are sectioned and stained with H&E stain

    Secondary Outcome Measures

    1. 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.

    2. Dosage requirement [1 - 2 hours]

      Dosage requirement of nanorobots and thus t-PA, mg

    3. Distribution of administrated nanorobots [1 - 2 hours]

      The distribution of administrated nanorobots. The position of nanorobots is tracked by MRI.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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
    2 Department of Obstetrics and Gynaecology, Prince of Wales Hospital Shatin New Territories Hong Kong

    Sponsors and Collaborators

    • Chinese University of Hong Kong

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ZHANG Li, Professor, Chinese University of Hong Kong
    ClinicalTrials.gov Identifier:
    NCT04644653
    Other Study ID Numbers:
    • 2020.384
    First Posted:
    Nov 25, 2020
    Last Update Posted:
    Mar 24, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 24, 2022