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Clinical Trial Summary

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.


Clinical Trial 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 ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00135850
Study type Interventional
Source Rigshospitalet, Denmark
Contact
Status Completed
Phase Phase 1/Phase 2
Start date March 2003
Completion date February 2005

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