Ex Vivo Test of New Stroke Treatment Using Magnetic Nanorobots

NCT04644653 | Unknown

• 1 other identifier: 2020.384
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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

Conditions

Thrombosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Stability of magnetic nanorobots

  1 - 2 hours

• Dosage requirement

  1 - 2 hours

• Distribution of administrated nanorobots

  1 - 2 hours

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (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

ACTIVE NOT RECRUITING

Department of Obstetrics and Gynaecology, Prince of Wales Hospital

Shatin, New Territories, Hong Kong

RECRUITING

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 25, 2020
• Study Start: September 1, 2020
• Primary Completion: August 31, 2025
• Study Completion: September 30, 2025
• Last Updated: March 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)