Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00279539
Status:
WITHDRAWN
Last Update Posted:
2015-04-01
First Post:
2006-01-17
Brief Title:
Stem Cell Mobilization and VEGF Gene Transfer for Heart Failure
Sponsor:
Losordo Douglas MD
Organization:
Losordo Douglas MD
Study Overview
Official Title:
phVEGF165 GENE TRANSFER TO PROMOTE ANGIOGENESIS IN PATIENTS WITH ISCHEMIC HEART FAILURE
Status:
WITHDRAWN
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study never started
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and bioactivity of intramyocardial gene transfer using VEGF vascular endothelial growth factor in patients with ischemic heart failure The research treatment of this CHF study will involve the use of an intramuscular injection with a catheter inserted in through the groin to transfer a type of DNA phVEGF165 gene to the wall of the heart Genes which are part of the DNA molecules carry instructions to allow the cells to produce specific proteins Gene transfer or treatment with DNA a necessary part of all cells is being studied for the treatment of patients with heart failure This research therapy which is experimental and not proven is designed to try to grow new blood vessels to improve blood flow to areas of the heart that are not receiving enough blood
DNA is present in all cells and provides the instructions for making proteins After delivering a piece of DNA containing the vascular endothelial growth factor 1 VEGF-1 gene the product being studied into cells the cells may produce a specific protein called vascular endothelial growth factor 1 VEGF-1 Animal studies have indicated that the VEGF-1 protein may cause new blood vessels to grow The Vascular Endothelial Growth Factor Gene ph VEGF 165 is found on the VEGF DNA Experiments performed in animals show that once in the heart wall the DNA directs the cells of the heart muscle to make the VEGF protein VEGF 165 is a protein that has been shown to stimulate cells known as endothelial cells which form the inner lining of blood vessels This protein causes cells to divide and grow thereby forming new blood vessels It is anticipated that this new blood supply may help the heart pump the blood more effectively and relieve some heart failure symptoms We do not yet have enough information to know what will happen in humans that is why we are doing this research
After gene transfer we will begin a process to help move some of the stem cells from the bone marrow into the blood circulation Subjects will be given the drug called G-CSF a drug used to move cells from the bone marrow into the blood stream Stem cells are young cells produced by bone marrow the spongy cavity in the center of large bones that can develop into blood cells or other types of cells This medication triggers the movement of stem cells out of the bone marrow and into the blood stream Before being released into the blood stream stem cells receive signals that direct them to become specific types of cells such as CD34 cells endothelial progenitor cells CD34 cells that move to or are in the area of damaged heart tissue may promote growth of new blood vessels that supply blood and nutrients and thereby improve the chance of survival of heart tissue improve heart function and possibly have a long-term benefit
We will be recruiting 12 subjects for this study There will be no randomization and no placebo group Once eligibility in the research study has been determined all subjects will be treated with the VEGF and G-CSF
DNA is present in all cells and provides the instructions for making proteins After delivering a piece of DNA containing the vascular endothelial growth factor 1 VEGF-1 gene the product being studied into cells the cells may produce a specific protein called vascular endothelial growth factor 1 VEGF-1 Animal studies have indicated that the VEGF-1 protein may cause new blood vessels to grow The Vascular Endothelial Growth Factor Gene ph VEGF 165 is found on the VEGF DNA Experiments performed in animals show that once in the heart wall the DNA directs the cells of the heart muscle to make the VEGF protein VEGF 165 is a protein that has been shown to stimulate cells known as endothelial cells which form the inner lining of blood vessels This protein causes cells to divide and grow thereby forming new blood vessels It is anticipated that this new blood supply may help the heart pump the blood more effectively and relieve some heart failure symptoms We do not yet have enough information to know what will happen in humans that is why we are doing this research
After gene transfer we will begin a process to help move some of the stem cells from the bone marrow into the blood circulation Subjects will be given the drug called G-CSF a drug used to move cells from the bone marrow into the blood stream Stem cells are young cells produced by bone marrow the spongy cavity in the center of large bones that can develop into blood cells or other types of cells This medication triggers the movement of stem cells out of the bone marrow and into the blood stream Before being released into the blood stream stem cells receive signals that direct them to become specific types of cells such as CD34 cells endothelial progenitor cells CD34 cells that move to or are in the area of damaged heart tissue may promote growth of new blood vessels that supply blood and nutrients and thereby improve the chance of survival of heart tissue improve heart function and possibly have a long-term benefit
We will be recruiting 12 subjects for this study There will be no randomization and no placebo group Once eligibility in the research study has been determined all subjects will be treated with the VEGF and G-CSF
Detailed Description:
None
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