Mesenchymal Stem Cell Administration in the Treatment of Coronary Graft Disease in Heart Transplant Patients

MES-HT is a phase 1-2 multicenter pilot prospective study conducted on 14 heart transplant patients who developed severe coronary vasculopathy, in the aim to assess the effect on myocardial perfusion of the intramyocardial administration by percutaneous way of autologous mesenchymal stem cells derived from the bone marrow.

The main objective is to show improvement in myocardial perfusion in a non-randomized and uncontrolled pilot study, before considering a randomized controlled study. The administration of intra myocardial cells using the NOGA system was carried out to date with more than 1,000 patients and is considered feasible and safe. However, the investigators will assess very carefully the feasibility and safety of this invasive approach.

The primary endpoint is the improvement of myocardial perfusion measured by MRI after endomyocardial injection of mesenchymal cells by percutaneous way, guided by the NOGA system.

The secondary endpoints are the feasibility and safety of this administration, changes in ejection fraction measured by contrast echocardiography, changes in other MRI cardiac parameters (left ventricular volumes , intramyocardial fibrosis), the oxygen consumption during exercise, myocardial perfusion measured by SPECT. Other secondary endpoints are the evolution of the immune status, and histological criteria of myocardial biopsy.

Once the mapping performed, preparation is injected through another catheter (MYOSTAR injection catheter) which will also be guided by the Noga® system. This catheter may be positioned on the regions of interest (viable ischemic areas) and allow the injection of the quantity of CSM (40 million / ml) in 10 to 12 different injection points and injection volumes 0.3 ml for a total dose of 120 to 144 million cells.