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

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

Study Overview

• Status: Recruiting
• Conditions: Thrombosis

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Hong Kong
  • New Territories
    • Shatin, New Territories, Hong Kong
      • Active, not recruiting
      • 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
      • Recruiting
      • Department of Obstetrics and Gynaecology, Prince of Wales Hospital
      • Contact: Pui Wah Chung, Doctor; Phone Number: (852) 35051537; Email: jacquelinechung@cuhk.edu.hk
      • Principal Investigator: Pui Wah Chung, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): August 31, 2025
• Study Completion (Anticipated): September 30, 2025

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: November 20, 2020
• First Posted (Actual): November 25, 2020

Study Record Updates

• Last Update Posted (Actual): March 24, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis
• Other Study ID Numbers: 2020.384

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No