The Effect of Mobilized Stem Cell by G-CSF and VEGF Gene Therapy in Patients With Stable Severe Angina Pectoris
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.
|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|
- Improvement in myocardial perfusion measured by single photon emission computerized tomography (SPECT)
- Clinical improvement
|Study Start Date:||March 2003|
|Study Completion Date:||February 2005|
|Primary Completion Date:||February 2005 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00135850
|Cardiac Catheterization Laboratory 2014, The Heart Centre, University Hospital, Rigshospitalet|
|Copenhagen Ø, Denmark, 2100|
|Principal Investigator:||Jens Kastrup, MD DMSc||Cardiac Catheterization Laboratory 2014, The Heart Centre, University Hospital, Rigshospitalet, DK-2100 Copenhagen Ø, Denmark|