Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00135850
Status:
COMPLETED
Last Update Posted:
2011-08-05
First Post:
2005-08-25
Brief Title:
The Effect of Mobilized Stem Cell by G-CSF and VEGF Gene Therapy in Patients With Stable Severe Angina Pectoris
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
The Effect of Mobilized Stem Cell by G-CSF and VEGF Gene Therapy in Patients With Stable Severe Angina Pectoris
Status:
COMPLETED
Status Verified Date:
2002-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None