Linked Life Data

14965381

Source:http://linkedlifedata.com/resource/pubmed/id/14965381

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
1
pubmed:dateCreated
2004-2-17
pubmed:abstractText
A recombinant virus vector constructed from adeno-associated virus (AAV) that has been altered to carry the human alpha1-antitrypsin (hAAT) gene expressed from a hybrid chicken beta-actin promoter with a cytomegalovirus enhancer has been developed. The construct has been shown to initiate the production of hAAT in animal models closely matching the proposed human trial. The proposed clinical trial is an open-label, phase I study administering recombinant adeno-associated virus alpha1-antitrypsin (rAAV2-CB-hAAT) gene vector intramuscularly to AAT-deficient human subjects where gene expression can be measured directly in blood samples to assess safety. Safety parameters will be measurement of changes in serum chemistries and hematology, urinalysis, pulmonary function testing, semen assay for vector genomes, immunologic response to AAT, and AAV, as well as reported subject history of any symptoms.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Jan
pubmed:issn
1043-0342
pubmed:author
pubmed:issnType
Print
pubmed:volume
15
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
93-128
pubmed:dateRevised
2006-4-21
pubmed:meshHeading
pubmed:year
2004
pubmed:articleTitle
Phase I trial of intramuscular injection of a recombinant adeno-associated virus alpha 1-antitrypsin (rAAV2-CB-hAAT) gene vector to AAT-deficient adults.
pubmed:affiliation
Department of Pediatrics, University of Florida, Gainesville, USA.
pubmed:publicationType
Journal Article, Clinical Trial, Clinical Trial, Phase I