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:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00135850
First received: August 25, 2005
Last updated: August 4, 2011
Last verified: October 2002
  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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 4, 2011
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
Coronary Artery Disease
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Chest Pain
Coronary Disease
Pain
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014