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

Terminated

• Conditions: Vascular Diseases

• Registration Number: NCT04122794
• Lead Sponsor: University Hospital of Limerick

Brief Summary

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.

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 Timeline

• Study First Submitted: 2019-10-09
• Study First Submitted QC: 2019-10-09
• Study First Posted: 2019-10-10
• Study Start: 2019-11-20
• Primary Completion: 2023-03-22
• Study Completion: 2024-03-22
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 13

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The identification of Endothelial Cell phenotype	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.

Trial Locations

Locations (1)

University Hospital Limerick; 🇮🇪 Limerick, Ireland