Ex Vivo Test of New Stroke Treatment Using Magnetic Nanorobots

NCT ID: NCT04644653

Last Updated: 2022-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2025-09-30

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

ZHANG Li

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Site Status: ACTIVE_NOT_RECRUITING

Department of Obstetrics and Gynaecology, Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Facility Contacts

Pui Wah Chung, Doctor

Role: primary

jacquelinechung@cuhk.edu.hk

(852) 35051537

Other Identifiers

2020.384

Identifier Type: -

Identifier Source: org_study_id