Safety issues related to retroviral-mediated gene transfer in humans.
The first three approved human clinical trials utilizing retroviral-mediated gene transfer are now underway. While this technology holds great promise for the study and treatment of human disease, it also poses a number of safety concerns. In evaluating clinical protocols, potential complications and the likelihood of their occurrence are estimated by review committees so that a risk/benefit assessment can be made. Current knowledge, reviewed in this article, suggests that no acute complications secondary to retroviral-mediated gene transfer are likely, but the possibility of long-term or unforeseen sequelae in patients suggests the need for post-treatment monitoring.
Cornetta
K
K
Molecular Hematology Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD 20892.
Morgan
R A
RA
Anderson
W F
WF
D000818:Animals; D002471:Cell Transformation, Neoplastic / Q000235:genetics; D003673:Defective Viruses / Q000235:genetics; D015316:Genetic Therapy / Q000009:adverse effects*; D005822:Genetic Vectors; D006801:Humans; D016254:Mutagenesis, Insertional; D009857:Oncogenes; D011323:Primates; D011995:Recombination, Genetic; D012190:Retroviridae / Q000235:genetics*; D018570:Risk Assessment; D012307:Risk Factors; D014162:Transfection; D014170:Transformation, Genetic; D014779:Virus Replication