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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00135850
First Posted: August 26, 2005
Last Update Posted: August 5, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rigshospitalet, Denmark
  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 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00135850     History of Changes
Other Study ID Numbers: Gene G-CSF
First Submitted: August 25, 2005
First Posted: August 26, 2005
Last Update Posted: August 5, 2011
Last Verified: October 2002

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

Additional relevant MeSH terms:
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Angina Pectoris
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms