The Role of Unsteady Wall Shears Stress Stimuli on Human Umbilical Vein Endothelial Cells Harvested From Umbilical Cords (HUVEC)

April 11, 2024 updated by: Fiona Leahy, University Hospital of Limerick

The Role of Unsteady Wall Shears Stress Stimuli on Human Umbilical Vein Endothelial Cells (HUVECs) Harvested From Umbilical Cords

The aim of this study is to obtain and test endothelial cells (EC's) from umbilical cords to examine specific properties of these cells which make up the inner lining of blood vessels.

Study Overview

Status

Terminated

Conditions

Detailed Description

Mechanical testing will be performed on the Ec's to see how the cells reacts and ultimately how the blood vessel is affected.

A central role in the mechanism that defines the nature of vessel remodelling is played by endothelial cells. EC's are extremely sensitive to the frictional forces exerted on a unit of the endothelial area by blood flow. This mechanical stimulus is known as wall shear stress (WSS). WSS experienced by EC's in-vivo is unsteady due to the unsteady nature of blood flow produced during the cardiac cycle and due to the complex nature of the vascular tree.

The extent to which this applies to venous cells and tissue remains unknown and it is the focus of this study.

Study Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Limerick, Ireland
        • University Hospital Limerick

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Women attending Maternity Services in Limerick who are pregnant and due for routine delivery that meet all the inclusion and exclusion criteria.

Description

Inclusion Criteria:

  • Patients who are attending the Maternity Services who are pregnant and due for routine delivery.
  • Aged 18- 40 years.
  • Are willing and capable to voluntarily sign a statement of informed consent to take part in this investigation.
  • Patients due to give birth to twins will be included in this study. Women having both "normal" delivery and caesarean section delivery will be included in this study.

Exclusion Criteria:

  • Patients unable to provide informed consent.
  • Patients who are under the age of 18 and over the age of 40 years.
  • Patients who are deemed unsuitable due to any circumstances as deemed appropriate by the Consultant.
  • Patients with a Blood Borne Virus (HIV Type 1, HIV Type 2, Hepatitis B, Hepatitis C) will be excluded from the study.
  • Patients with diabetes that is not gestational in nature will be excluded from this study.
  • Patients due to deliver triplets or more will be excluded from this study.
  • Patients who deliver their baby before 37 weeks gestation will not have umbilical cord tissue retained for study purposes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The identification of Endothelial Cell phenotype
Time Frame: 2 years
To identify this phenotype by assessing the endothelial identity markers, the endothelial to mesenchymal transition markers and the regulation of genes involved in EC quiescence.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Limerick

Collaborators

University of Limerick

Investigators

  • Principal Investigator: Eamon Kavanagh, MD FRCSI, University Hospital of Limerick

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2019

Primary Completion (Actual)

March 22, 2023

Study Completion (Actual)

March 22, 2024

Study Registration Dates

First Submitted

October 9, 2019

First Submitted That Met QC Criteria

October 9, 2019

First Posted (Actual)

October 10, 2019

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DVS006

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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