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

This study has been completed.
Information provided by:
Rigshospitalet, Denmark Identifier:
First received: August 25, 2005
Last updated: August 4, 2011
Last verified: October 2002

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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:

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
Study Completion Date: February 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
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


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

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 identifier: NCT00135850

Cardiac Catheterization Laboratory 2014, The Heart Centre, University Hospital, Rigshospitalet
Copenhagen Ø, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
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 Identifier: NCT00135850     History of Changes
Other Study ID Numbers: Gene G-CSF
Study First Received: August 25, 2005
Last Updated: August 4, 2011
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Rigshospitalet, Denmark:
Gene therapy
Stem cells
myocardial ischemia

Additional relevant MeSH terms:
Angina Pectoris
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Signs and Symptoms
Coronary Disease
Arterial Occlusive Diseases processed this record on April 23, 2014