Administration of AdVEGF-All6A+ to Myocardium of Individuals With Diffuse

Status Withdrawn

Clinical Trial Summary

The proposed Phase I/II 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, multinational/multi-center, placebo controlled study.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01757223
Study type	Interventional
Source	Weill Medical College of Cornell University
Contact
Status	Withdrawn
Phase	Phase 1/Phase 2
Start date	December 2020
Completion date	October 2030

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Administration of AdVEGF-All6A+ to Myocardium of Individuals With Diffuse CAD Via Minimally Invasive Surgery

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms