Clinical trial NCT04644653: Ex Vivo Test of New Stroke Treatment Using Magnetic Nanorobots
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thrombosis
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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


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)

Primary outcomes:
measure: Thrombolysis performance
timeFrame: 1 -2 hours
measure: Time for recanalization
timeFrame: 1 -2 hours
measure: Damage to vessels
timeFrame: 1 -2 hours
Secondary outcomes:
measure: Stability of magnetic nanorobots
timeFrame: 1 - 2 hours
measure: Dosage requirement
timeFrame: 1 - 2 hours
measure: Distribution of administrated nanorobots
timeFrame: 1 - 2 hours
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: 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
state: New Territories
city: Shatin
country: Hong Kong
facility: Department of Obstetrics and Gynaecology, Prince of Wales Hospital
state: New Territories
Study officials:
References: