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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00135850

Enrollment

Registered

2005-08-26

Start date

2003-03-31

Completion date

2005-02-28

Last updated

2011-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Heart Disease

Keywords

Gene therapy, VEGF, Stem cells, myocardial ischemia, angiogenesis

Brief summary

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

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

Interventions

GENETICVEGF-A165 plasmid

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

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

* 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

Design outcomes

Primary

Measure	Time frame
Improvement in myocardial perfusion measured by single photon emission computerized tomography (SPECT)	—

Secondary

Measure	Time frame
Clinical improvement	—

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026