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

Phase 1

Completed

• Conditions: Ischemic Heart Disease

• Registration Number: NCT00135850
• Lead Sponsor: Rigshospitalet, Denmark

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

Study Timeline

• Status Verified: 2002-10
• Study Start: 2003-03
• Primary Completion: 2005-02
• Study Completion: 2005-02
• Study First Submitted: 2005-08-25
• Study First Submitted QC: 2005-08-25
• Study First Posted: 2005-08-26
• Last Update Submitted: 2011-08-04
• Last Update Posted: 2011-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Improvement in myocardial perfusion measured by single photon emission computerized tomography (SPECT)

Secondary Outcome Measures

Name	Time	Method
Clinical improvement

Trial Locations

Locations (1)

Cardiac Catheterization Laboratory 2014, The Heart Centre, University Hospital, Rigshospitalet; 🇩🇰 Copenhagen Ø, Denmark