The Effect of Mobilized Stem Cell by G-CSF and VEGF Gene Therapy in Patients With Stable Severe Angina Pectoris

In recent clinical trials, vascular endothelial growth factor (VEGF) delivered as plasmid DNA percutaneously by a catheter-based, intramyocardial approach, have been demonstrated to be safe and to be associated with a reduction in angina and an increase in exercise time or an improvement in regional wall motion in "no-option patients" with chronic myocardial ischemia.

It has been demonstrated, that BM-derived stem cells mobilized by cytokines as granulocyte colony stimulating factor (G-CSF) were capable of regenerating the myocardial tissue, leading to improve the survival and cardiac function after myocardial infarction.

These data suggested that a combination therapy with exogenous administration of gene vascular growth factor combined with G-CSF mobilization of bone marrow stem cells might induce both angiogenesis and vasculogenesis in ischemic myocardium

Inclusion criteria

• Reversible ischemia at an adenosine stress single photon emission computerized tomography (SPECT)
• A coronary arteriography demonstrating at least one main coronary vessel from which new collaterals/vessels could be supplied
• Age above 18 years
• Canadian Cardiovascular Society angina classification (CCS) > 3.

Exclusion criteria

• Ejection fraction <0.40
• Unstable angina pectoris
• Acute myocardial infarction within the last three months
• Diabetes mellitus with proliferative retinopathy
• Diagnosed or suspected cancer disease
• Chronic inflammatory disease
• Premenopausal women