title: 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.
abstract: This 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.
authors.affiliation: Scripps Clinic, Green Hospital, La Jolla, California 92037, USA.
authors.forename: F David
authors.initials: FD
authors.lastname: Fortuin
authors.forename: Peter
authors.initials: P
authors.lastname: Vale
authors.forename: Douglas W
authors.initials: DW
authors.lastname: Losordo
authors.forename: James
authors.initials: J
authors.lastname: Symes
authors.forename: Giacomo A
authors.initials: GA
authors.lastname: DeLaria
authors.forename: J Jeffrey
authors.initials: JJ
authors.lastname: Tyner
authors.forename: Gary L
authors.initials: GL
authors.lastname: Schaer
authors.forename: Robert
authors.initials: R
authors.lastname: March
authors.forename: R Jeffrey
authors.initials: RJ
authors.lastname: Snell
authors.forename: Timothy D
authors.initials: TD
authors.lastname: Henry
authors.forename: Joseph
authors.initials: J
authors.lastname: Van Camp
authors.forename: John J
authors.initials: JJ
authors.lastname: Lopez
authors.forename: Wayne
authors.initials: W
authors.lastname: Richenbacher
authors.forename: Jeffrey M
authors.initials: JM
authors.lastname: Isner
authors.forename: Richard A
authors.initials: RA
authors.lastname: Schatz
mesh_terms: D000328:Adult; D000368:Aged; D004247:DNA / Q000008:administration & dosage*; D016228:Endothelial Growth Factors / Q000235:genetics*; D005500:Follow-Up Studies; D018014:Gene Transfer Techniques / Q000009:adverse effects; D015316:Genetic Therapy / Q000009:adverse effects; D006801:Humans; D007267:Injections; D036341:Intercellular Signaling Peptides and Proteins / Q000235:genetics*; D008222:Lymphokines / Q000235:genetics*; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000503:physiopathology / Q000628:therapy*; D009206:Myocardium; D018919:Neovascularization, Physiologic; D011446:Prospective Studies; D013908:Thoracotomy; D042461:Vascular Endothelial Growth Factor A; D042442:Vascular Endothelial Growth Factors
chemical_list: D016228:Endothelial Growth Factors; D036341:Intercellular Signaling Peptides and Proteins; D008222:Lymphokines; D042461:Vascular Endothelial Growth Factor A; D042442:Vascular Endothelial Growth Factors; D004247:DNA