Tracking Endothelial Cells in Arterial Injury

Status Completed

Clinical Trial Summary

We plan to track the migratory behaviour of culture-expanded enothelial outgrowth cells in the context of vascular injury sustained during elective coronary angiography. We will use Flouro-deoxyglucose-labelling and PET-CT to track the endothelial cells.

Clinical Trial Description

The radial artery is commonly injured following trans-radial cardiac catheterisation and this injury can be demonstrated as a reduction in endothelial function as measured by flow-mediated dilatation which recovers with time (13-15). Thus the radial artery is useful as a model of mechanical arterial injury as radial artery trauma is common and endothelial function can be followed longitudinally with a non-invasive test. Endothelial progenitor cells localise to sites of arterial injury in animal models both in vitro and in vivo and accelerate re-endothelialisation as well as attenuating neointimal hyperplasia (16-18), This has however not been demonstrated in man. Our research group, in collaboration with the Scottish Blood Transfusion Service (SNBTS) have developed a good manufacturing practice (GMP)-compliant process for manufacturing an endothelial progenitor cell (EPC) product (SNBTS will manufacture the final product administered to patients). We have also demonstrated in vitro that we can label these cells with the radioisotope 18 F-fluorodeoxyglucose (18F-FDG) and that activity can be detected in as few as 200 cells using a hybrid positron emission and computed tomography (PET-CT) scanner (Biograph mCT Siemens Medical Systems, Erlangen, Germany). We will therefore be able to track the fate of these cells in vivo. The major potential advantage of imaging in this way is that only 18F-FDG associated with EPCs will be delivered to the patient, removing the issue of background attenuation due to "free" circulating 18F-FDG. A similar technique has previously been employed in vivo to track homing of unselected autologous bone marrow cells to infarcted myocardium(19). Following intracoronary delivery using this technique, the authors were able to detect 1.3% - 2.6% of 18F-FDG-labelled cells in the infarcted myocardium. Demonstrating that EPCs are able to home to and integrate at sites of vascular injury in man is a critical step in understanding the role of EPCs in vascular repair ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02975518
Study type	Interventional
Source	University of Edinburgh
Contact
Status	Completed
Phase	N/A
Start date	December 2015
Completion date	March 12, 2018

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.