Ischemic cardiomyopathy and the C-Cure programme

This highly informative session discussing the C-cure programme gathered rapt attention from the audience in Room 5 yesterday. Chaired by William Wijns and co-chaired by Josef Bartunek, the session discussed the C-cure programme.

Session attendees learned that contrary to previous approaches in the use of stem cells to aid failing myocardium, the C-cure programme uses stem cells that have been primed, using a concoction of specific growth factors, to develop into the cardiopoeitic lineage as myocardial progenitor cells. These cells go through strict good manufacturing processes, including sterility controls and screening to ensure only those cells that have been fully primed are used in patients.

Excellent recorded cases during the session showed a patients perspective, harvesting and cell handling of bone marrow, practice of cell differentiation and a clinical case from C-cure.

The C-cure programme is a multi-centre, randomised (2:1), open-label, two-stage trial of 240 patients. During Stage A, initial safety is established and in Stage B efficacy is examined.

Eligible patients were those with cardiomyopathy, previous MI, an ejection fraction of 15-40% and who were symptomatic.

Patients selected were those for whom all other treatment options had failed (CRT, CABG etc). The primary endpoint will be change in NOGA-derived ejection fractions.

A recorded case was used to maximum effect by showing how cells are delivered by injection using NOGA mapping to determine the exact myocardial site of cell delivery. Delegates saw how NOGA mapping works by using electromechanical guidance to generate a 3D map of the left ventricle. Areas displaying no voltage indicated dead myocardium while areas with no 'shortening' but voltage, indicated weakened myocardium.This is where cells are delivered.

The process of delivery involves generating the myocardial map, identifying the target area and using the injection catheter to guide and deliver the cells to that area. This was a fascinating session demonstrating the potential for second generation stem cell products to meet the unmet need!