One-year follow-up of direct myocardial gene transfer of vascular endothelial growth factor-2 using naked plasmid deoxyribonucleic acid by way of thoracotomy in no-option patients**Drs. Isner and Schatz are stockholders of Vascular Genetics, Inc., the sponsor of this trial.
2003; Elsevier BV; Volume: 92; Issue: 4 Linguagem: Inglês
10.1016/s0002-9149(03)00661-1
ISSN1879-1913
AutoresF. David Fortuin, Peter R. Vale, Douglas W. Losordo, James F. Symes, Giacomo A. DeLaria, Jeffrey Tyner, Gary L. Schaer, Robert March, R. Jeffrey Snell, Timothy D. Henry, Joseph Van Camp, John J. López, Wayne Richenbacher, Jeffrey M. Isner, Richard A. Schatz,
Tópico(s)Cardiac and Coronary Surgery Techniques
ResumoThis phase I open label, dose-escalating study shows that gene transfer of vascular endothelial growth factor-2 naked deoxyribonucleic acid by direct myocardial injection by way of thoracotomy in patients with Canadian Cardiovascular Society class 3 or 4 angina is feasible and safe. The procedure is well tolerated, with few major adverse cardiac events at 1 year, and without complications directly related to gene expression. In this prospective, nonblinded study, the procedure is associated with clinical improvement; however, there was no angiographic evidence of angiogenesis and there is a great potential for a sham or placebo effect in the study patients. A randomized phase III trial is underway that will help determine the efficacy of vascular endothelial growth factor-2 gene transfer in "no-option" patients.
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