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

NCT ID: NCT00135850

Last Updated: 2011-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2005-02-28

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

Conditions

Ischemic Heart Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

VEGF-A165 plasmid

Intervention Type: GENETIC

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Principal Investigators

Jens Kastrup, MD DMSc

Role: PRINCIPAL_INVESTIGATOR

Cardiac Catheterization Laboratory 2014, The Heart Centre, University Hospital, Rigshospitalet, DK-2100 Copenhagen Ø, Denmark

Locations

Cardiac Catheterization Laboratory 2014, The Heart Centre, University Hospital, Rigshospitalet

Copenhagen Ø, , Denmark

Countries

Denmark

Other Identifiers

Gene G-CSF

Identifier Type: -

Identifier Source: org_study_id