Publication Type	Academic Article
Authors	Mohler E, Rajagopalan S, Olin J, Trachtenberg J, Rasmussen H, Pak R, Crystal R
Journal	Vasc Med
Volume	8
Issue	1
Pagination	9-13
Date Published	01/01/2003
ISSN	1358-863X
Keywords	Adenoviridae, Angiogenesis Inducing Agents, Angiogenic Proteins, Endothelial Growth Factors, Gene Transfer Techniques, Ischemia, Lower Extremity, Lymphokines, Peripheral Vascular Diseases, Vascular Endothelial Growth Factor A
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.
DOI	10.1191/1358863x03vm460oa
PubMed ID	12866606