Adenoviral-mediated gene transfer of vascular endothelial growth factor in critical limb ischemia: safety results from a phase I trial.
Vasc Med
; 8(1): 9-13, 2003.
Article
em En
| MEDLINE
| ID: mdl-12866606
ABSTRACT
Critical limb ischemia (CLI) is typified by rest pain and/or tissue necrosis secondary to advanced peripheral arterial disease (PAD) and is characterized by diminution in limb perfusion at rest. We tested the safety of an angiogenic strategy with CI-1023 (Ad(GV)VEGF121.10), a replication-deficient adenovirus encoding human vascular endothelial growth factor isoform 121 in patients with CLI as part of a phase I trial. Fifteen subjects >35 years of age with CLI and angiographic disease involving the infra-inguinal vessels underwent intramuscular injection of CI-1023 (4 x 10(8) to 4 x 10(10) particle units, n = 13) or placebo (n = 2). All of the patients tolerated the injection well and there were no serious complications related to the procedure. Transient edema was noted in one patient. A total of 79 adverse events were reported over the course of one year. One death (day 136) and one malignancy (day 332) occurred in the CI-1023 group. CI-1023 appears to be well tolerated and safe for single-dose administration in patients with critical limb ischemia due to PAD. Further studies are needed to determine the efficacy of this form of therapeutic angiogenesis.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Adenoviridae
/
Fatores de Crescimento Endotelial
/
Linfocinas
/
Doenças Vasculares Periféricas
/
Técnicas de Transferência de Genes
/
Extremidade Inferior
/
Proteínas Angiogênicas
/
Fator A de Crescimento do Endotélio Vascular
/
Indutores da Angiogênese
/
Isquemia
Tipo de estudo:
Clinical_trials
Limite:
Adult
/
Aged
/
Aged80
/
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
Vasc Med
Assunto da revista:
ANGIOLOGIA
Ano de publicação:
2003
Tipo de documento:
Article
País de afiliação:
Estados Unidos