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| 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 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 |
Gene Transfer: VEGF-A165 plasmid |
Phase I Phase II |
| MedlinePlus related topics: | Angina Heart Diseases |
| ChemIDplus related topics: | Granulocyte colony-stimulating factor |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | The Effect of Mobilized Stem Cell by G-CSF and VEGF Gene Therapy in Patients With Stable Severe Angina Pectoris |
| Estimated Enrollment: | 48 |
| Study Start Date: | March 2003 |
| Estimated Study Completion Date: | February 2005 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Denmark | |||||
| Cardiac Catheterization Laboratory 2014, The Heart Centre, University Hospital, Rigshospitalet | |||||
| Copenhagen Ø, Denmark, 2100 | |||||
| Rigshospitalet, Denmark |
| Principal Investigator: | Jens Kastrup, MD DMSc | Cardiac Catheterization Laboratory 2014, The Heart Centre, University Hospital, Rigshospitalet, DK-2100 Copenhagen Ø, Denmark |
More Information
| Study ID Numbers: | Gene G-CSF |
| First Received: | August 25, 2005 |
| Last Updated: | December 7, 2005 |
| ClinicalTrials.gov Identifier: | NCT00135850 |
| Health Authority: | Denmark: Danish Medicines Agency |
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