Linked Life Data

12095313

Source:http://linkedlifedata.com/resource/pubmed/id/12095313

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
1
pubmed:dateCreated
2002-7-3
pubmed:abstractText
Vascular endothelial growth factor (VEGF) gene therapy may be useful for the treatment of lower-limb ischemia. The objectives of this study were to evaluate safety and angiographic and hemodynamic responses of local catheter-mediated VEGF gene therapy in ischemic lower-limb arteries after percutaneous transluminal angioplasty (PTA). For this study, we recruited patients with chronic lower-limb ischemia and atherosclerotic infrainguinal occlusion or stenosis suitable for PTA. In the study, 18 patients received 2x10(10) plaque-forming units (pfu) VEGF-adenovirus (VEGF-Ad), 17 patients received VEGF-plasmid/liposome (VEGF-P/L; 2000 microg of VEGF plasmid, 2000 microl of DOTMA:DOPE), and 19 control patients received Ringer's lactate at the angioplasty site. Digital subtraction angiography (DSA) was used to evaluate vascularity before, immediately after, and 3 months after the PTA. Clinical follow-up data, basic laboratory tests, and ankle-brachial index (ABI) were evaluated. Primary endpoint was DSA analysis of vascularity, and secondary endpoints were restenosis rate, Rutherford class, and ABI after 3 months follow-up. No major gene transfer-related side effects or differences in laboratory tests were detected between the study groups. However, anti-adenovirus antibodies increased in 61% of the patients treated with VEGF-Ad. For the primary endpoint, follow-up DSA revealed increased vascularity in the VEGF-treated groups distally to the gene transfer site (VEGF-Ad P=0.03, VEGFP/L P=0.02) and in the VEGF-Ad group in the region of the clinically most severe ischemia (P=0.01). As for the secondary endpoints, mean Rutherford class and ABI showed statistically significant improvements in the VEGF-Ad and VEGF-P/L groups, but similar improvements were also seen in the control patients. We conclude that catheter-mediated VEGF gene therapy is safe and well tolerated. Angiography demonstrated that VEGF gene transfer increased vascularity after PTA in both VEGF-Ad- and VEGF-P/L-treated groups.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Jul
pubmed:issn
1525-0016
pubmed:author
pubmed:issnType
Print
pubmed:volume
6
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
127-33
pubmed:dateRevised
2006-11-15
pubmed:meshHeading
pubmed-meshheading:12095313-Adenoviridae, pubmed-meshheading:12095313-Aged, pubmed-meshheading:12095313-Aged, 80 and over, pubmed-meshheading:12095313-Angiography, Digital Subtraction, pubmed-meshheading:12095313-Angioplasty, Balloon, pubmed-meshheading:12095313-Arterial Occlusive Diseases, pubmed-meshheading:12095313-Endothelial Growth Factors, pubmed-meshheading:12095313-Female, pubmed-meshheading:12095313-Gene Therapy, pubmed-meshheading:12095313-Genetic Vectors, pubmed-meshheading:12095313-Humans, pubmed-meshheading:12095313-Intercellular Signaling Peptides and Proteins, pubmed-meshheading:12095313-Ischemia, pubmed-meshheading:12095313-Leg, pubmed-meshheading:12095313-Liposomes, pubmed-meshheading:12095313-Lymphokines, pubmed-meshheading:12095313-Male, pubmed-meshheading:12095313-Middle Aged, pubmed-meshheading:12095313-Neovascularization, Physiologic, pubmed-meshheading:12095313-Vascular Endothelial Growth Factor A, pubmed-meshheading:12095313-Vascular Endothelial Growth Factors
pubmed:year
2002
pubmed:articleTitle
Increased vascularity detected by digital subtraction angiography after VEGF gene transfer to human lower limb artery: a randomized, placebo-controlled, double-blinded phase II study.
pubmed:affiliation
Department of Surgery, University of Kuopio, Kuopio, Finland.
pubmed:publicationType
Journal Article, Clinical Trial, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Clinical Trial, Phase II