Tracking Endothelial Cells in Arterial Injury
Condition: Endothelial Progenitor Cells; Coronary Artery Disease; Vascular Injury; Coronary Angiography
MeSH terms: Coronary Artery Disease; Vascular System Injuries
Study type: Interventional

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.
    

Detailed 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
    

Intervention name(s): Administration of radio labelled endothelial outgrowth cells
Intervention type(s): Biological
Intervention description(s): Radio labelled endothelial outgrowth cells will be administered to patients undergoing elective coronary angiography and stenting. They will be administered intra-venously and intra-arterially (right radial artery) in separate arms. Migratory behaviour of these cells will be defined using PET CT. Intra-venous and intra-arterial injection of free radio tracer will serve as a control comparator arms.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science