Ex Vivo Test of New Stroke Treatment Using Magnetic Nanorobots

Thrombosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04644653
• Other study ID #: 2020.384
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: September 30, 2025

Study information

• Verified date: March 2022
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Thrombosis

Locations

Country	Name	City	State
Hong Kong	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

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thrombolysis performance	Size of thrombus by angiography, mm	1 -2 hours
Primary	Time for recanalization	Time for recanalization of occluded vessels, mins	1 -2 hours
Primary	Damage to vessels	Histological damage evaluation. The vessels are sectioned and stained with H&E stain	1 -2 hours
Secondary	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
Secondary	Dosage requirement	Dosage requirement of nanorobots and thus t-PA, mg	1 - 2 hours
Secondary	Distribution of administrated nanorobots	The distribution of administrated nanorobots. The position of nanorobots is tracked by MRI.	1 - 2 hours