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.
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.
Fortuin
F David
FD
Scripps Clinic, Green Hospital, La Jolla, California 92037, USA.
Vale
Peter
P
Losordo
Douglas W
DW
Symes
James
J
DeLaria
Giacomo A
GA
Tyner
J Jeffrey
JJ
Schaer
Gary L
GL
March
Robert
R
Snell
R Jeffrey
RJ
Henry
Timothy D
TD
Van Camp
Joseph
J
Lopez
John J
JJ
Richenbacher
Wayne
W
Isner
Jeffrey M
JM
Schatz
Richard A
RA
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
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