Ignite Creation Date:
2024-05-06 @ 1:12 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01757223
Status:
WITHDRAWN
Last Update Posted:
2021-01-27
First Post:
2012-10-10
Brief Title:
Administration of AdVEGF-All6A to Myocardium of Individuals With Diffuse CAD Via Minimally Invasive Surgery
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Phase III Study Administration of AdVEGF-All6A a Replication Deficient Adenovirus Vector Expressing a cDNAGenomic Hybrid of Human Vascular Endothelial Growth Factor to the Ischemic Myocardium
Status:
WITHDRAWN
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closure due to lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The proposed Phase III clinical trial will be used to determine the safety and toxicity of direct administration of the vector AdVEGF-All6A to the ischemic myocardium and to generate preliminary evidence regarding whether direct administration of AdVEGF-All6A to the ischemic myocardium will induce growth of collateral blood vessels and improve cardiac function This is a three-part multinationalmulti-center placebo controlled study
Detailed Description:
Coronary artery disease CAD is the predominant cause of heart failure a major cause of death and disability throughout the world Although prognosis of patients with CAD has been greatly improved by advances in cardiovascular treatment it is still the first cause of death in the USA Treatment options for CAD include diet exercise medication balloon angioplasty with or without stenting atherectomy and bypass surgery For many patients however the disease is diffuse and stenting or bypass surgery is not an option A new strategy to treat these patients is to use gene therapy to induce new networks of new blood vessels to bypass the arterial system that is blocked thus providing circulation to deliver oxygen needed by the tissue By administering a gene coding for vascular endothelial growth factor VEGF to the myocardium new networks of blood vessels can be created using the genetic material for VEGF In experimental animal studies VEGF is effective at treating ischemia of organs and is safe The most direct method of transferring genes to myocardium is by injection under direct vision during a minimally invasive thoracic surgery For the present study the VEGF gene will be delivered to the myocardium using a modified adenovirus Ad as a carrier The study is designed to test the safety and efficacy of AdVEGF-All6A
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1201-1145 | OTHER | Recombinant DNA Advisory Commitee | None |