This Phase 1/2 study examines granulocyte colony stimulating factor (G-CSF) given alone and in combination with vascular endothelial growth factor (VEGF) gene therapy using a VEGF-A165 plasmid in adults with severe chronic occlusive coronary artery disease and stable severe angina pectoris. The aim is to evaluate the mobilization of mesenchymal and haematopoietic stem cells from the bone marrow. Participants must be over 18, have reversible ischemia on stress imaging and a Canadian Cardiovascular Society (CCS) angina class above 3.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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