Document Detail


Six-month assessment of a phase I trial of angiogenic gene therapy for the treatment of coronary artery disease using direct intramyocardial administration of an adenovirus vector expressing the VEGF121 cDNA.
MedLine Citation:
PMID:  10522716     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To summarize the 6-month follow-up of a cohort of patients with clinically significant coronary artery disease who received direct myocardial injection of an E1-E3- adenovirus (Ad) gene transfer vector (Ad(GV)VEGF121.10) expressing the human vascular endothelial growth factor (VEGF) 121 cDNA to induce therapeutic angiogenesis.
BACKGROUND: Therapeutic angiogenesis describes a novel approach to the treatment of vascular occlusive disease that uses the administration of growth factors known to induce neovascularization of ischemic tissues.
METHODS: Direct myocardial injection of Ad(GV)VEGF121.10 into an area of reversible ischemia was carried out in 21 patients as an adjunct to conventional coronary artery bypass grafting (group A, n = 15) or as sole therapy using a minithoracotomy (group B, n = 6).
RESULTS: No evidence of systemic or cardiac-related adverse events related to vector administration was observed up to 6 months after therapy. Trends toward improvement in angina class and exercise treadmill testing at 6-month follow-up in the sole therapy group suggest the effects of this therapy are persistent for > or =6 months.
CONCLUSIONS: This study suggests that direct myocardial administration of Ad(GV)VEGF121.10 appears to be well tolerated in patients with clinically significant coronary artery disease. Initiation of phase II evaluation of this therapy appears warranted.
Authors:
T K Rosengart; L Y Lee; S R Patel; P D Kligfield; P M Okin; N R Hackett; O W Isom; R G Crystal
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase I; Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Annals of surgery     Volume:  230     ISSN:  0003-4932     ISO Abbreviation:  Ann. Surg.     Publication Date:  1999 Oct 
Date Detail:
Created Date:  1999-11-16     Completed Date:  1999-11-16     Revised Date:  2013-06-11    
Medline Journal Info:
Nlm Unique ID:  0372354     Medline TA:  Ann Surg     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  466-70; discussion 470-2     Citation Subset:  AIM; IM    
Affiliation:
Department of Cardiothoracic Surgery, Weill Medical College of Cornell University-New York Presbyterian Hospital, New York City 10021, USA.
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MeSH Terms
Descriptor/Qualifier:
Adenoviridae
Adolescent
Adult
Aged
Aged, 80 and over
Coronary Disease / therapy*
DNA, Complementary / administration & dosage*
Endothelial Growth Factors / genetics*
Female
Gene Transfer Techniques*
Genetic Therapy / methods*
Humans
Lymphokines / genetics*
Male
Middle Aged
Time Factors
Vascular Endothelial Growth Factor A
Vascular Endothelial Growth Factors
Grant Support
ID/Acronym/Agency:
M01RR00047/RR/NCRR NIH HHS; R01 HL 57318/HL/NHLBI NIH HHS
Chemical
Reg. No./Substance:
0/DNA, Complementary; 0/Endothelial Growth Factors; 0/Lymphokines; 0/VEGFA protein, human; 0/Vascular Endothelial Growth Factor A; 0/Vascular Endothelial Growth Factors
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