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

Rigshospitalet

Status and phase

Completed

Phase 2

Phase 1

Conditions

Ischemic Heart Disease

Treatments

Genetic: VEGF-A165 plasmid

Study type

Interventional

Funder types

Other

Identifiers

NCT00135850

Gene G-CSF

Details and patient eligibility

About

The aim of this study was to evaluate the mobilization of non-haematopoietic mesenchymal and haematopoietic stem cells from the bone marrow with granulocyte colony stimulating factor (G-CSF) treatment alone and in combination with vascular endothelial growth factor (VEGF) gene therapy in patients with severe chronic occlusive coronary artery disease.

Full description

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

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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