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

Sponsor:	Rigshospitalet, Denmark
Information provided by:	Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00135850

Purpose

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.

Condition	Intervention	Phase
Ischemic Heart Disease	Genetic: VEGF-A165 plasmid	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Control: Placebo Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Effect of Mobilized Stem Cell by G-CSF and VEGF Gene Therapy in Patients With Stable Severe Angina Pectoris

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Angina Heart Diseases

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Clinical improvement

Estimated Enrollment:	48
Study Start Date:	March 2003
Estimated Study Completion Date:	February 2005

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

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135850

Locations

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

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

Principal Investigator:

Jens Kastrup, MD DMSc

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

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00135850 History of Changes
Other Study ID Numbers:	Gene G-CSF
Study First Received:	August 25, 2005
Last Updated:	December 7, 2005
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Rigshospitalet, Denmark:

Gene therapy
VEGF
Stem cells
myocardial ischemia
angiogenesis

Additional relevant MeSH terms:

Angina Pectoris
Heart Diseases
Myocardial Ischemia
Cardiovascular Diseases

Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 01, 2010