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


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Ischemic Heart Disease


Clinical Trial: 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.

Sponsored by: 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 G-CSF treatment alone and in combination with VEGF gene therapy in patients with severe chronic occlusive coronary artery disease
Condition Intervention Phase
Ischemic Heart Disease
 Gene Transfer: VEGF-A165 plasmid
Phase I
Phase II

MedlinePlus related topics:  Coronary Disease;   Heart Diseases;   Vascular Diseases

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Study Details: 
Primary Outcomes: Improvement in myocardial perfusion measured by SPECT
Secondary Outcomes: Clinical improvement
Expected Total Enrollment:  48

Study start: March 2003;  Study completion: January 2006
Last follow-up: February 2005;  Data entry closure: January 2006

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   -   80 Years,  Genders Eligible for Study:  Both
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 and premenopausal women

Location Information


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

Study chairs or principal investigators

Jens Kastrup, MD DMSc,  Principal Investigator,  Cardiac Catheterization Laboratory 2014, The Heart Centre, University Hospital, Rigshospitalet, DK-2100 Copenhagen Ø, Denmark   

More Information

Study ID Numbers:  Gene G-CSF
Last Updated:  August 25, 2005
Record first received:  August 25, 2005
ClinicalTrials.gov Identifier:  NCT00135850
Health Authority: Denmark: Danish Medicines Agency
ClinicalTrials.gov processed this record on 2005-08-30


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October 6, 2008



Page Updated: September 6, 2005
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