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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Ischemic Heart Disease

Intervention / Treatment
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* Genetic: VEGF-A165 plasmid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: VEGF-A165 plasmid|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in myocardial perfusion measured by single photon emission computerized tomography (SPECT) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gene therapy, VEGF, Stem cells, myocardial ischemia, angiogenesis