Document Detail

Safety profile of plasmid/liposomes and virus vectors in clinical gene therapy.
MedLine Citation:
PMID:  18690935     Owner:  NLM     Status:  MEDLINE    
Despite of more than 500 gene therapy trials worldwide very little systematic safety information is available from gene therapy. Safety information was collected from 146 consecutive patients who participated in three randomized, controlled phase II gene therapy trials in cardiovascular diseases and malignant glioma using adenoviruses, plasmid/liposomes and retrovirus packaging cells. Total follow-up time of the patients was 78794 days which equals 1.5 years per patient. The main outcome measures were serious adverse events, other adverse events and changes in general laboratory parameters. Except fever and increases in CRP values plasmid/liposomes were safe and well tolerated. The incidence of serious adverse events in adenovirus-treated patients was 0.9 and 4.0/10000 patient days in cardiovascular and malignant glioma trials as compared to 0.5 and 2.1 in randomized control patients, respectively. Transient fever, leukopenia and increases in CRP and liver enzymes were detected in virus-treated patients. No deaths from side effects or no new cancers were associated with gene therapy. It is concluded that gene therapy, like any other therapy, is associated with side effects which depend on the administered vector, dose, and route of delivery and properties of the transgene. However, given the limitations of this study and length of the follow-up, the safety profile of gene therapy seems to be acceptable for the treatment of severe human diseases.
Thomas Wirth; Marja Hedman; Kimmo Mäkinen; Hannu Manninen; Arto Immonen; Matti Vapalahti; Seppo Ylä-Herttuala
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Current drug safety     Volume:  1     ISSN:  1574-8863     ISO Abbreviation:  Curr Drug Saf     Publication Date:  2006 Aug 
Date Detail:
Created Date:  2008-08-11     Completed Date:  2008-09-03     Revised Date:  2012-07-19    
Medline Journal Info:
Nlm Unique ID:  101270895     Medline TA:  Curr Drug Saf     Country:  Unknown    
Other Details:
Languages:  eng     Pagination:  253-7     Citation Subset:  IM    
A.I. Virtanen Institute, Kuopio University Hospital, Kuopio, Finland.
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MeSH Terms
Adenoviridae / genetics
Cardiovascular Diseases / complications,  therapy
Clinical Trials, Phase II as Topic
Dose-Response Relationship, Drug
Drug Carriers
Follow-Up Studies
Gene Therapy / adverse effects*,  mortality
Genetic Vectors / adverse effects*
Glioma / complications,  therapy
Liposomes / adverse effects*
Middle Aged
Plasmids / adverse effects*,  genetics
Randomized Controlled Trials as Topic
Reg. No./Substance:
0/Drug Carriers; 0/Liposomes

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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