title: Safety issues related to retroviral-mediated gene transfer in humans.
abstract: 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.
authors.affiliation: Molecular Hematology Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD 20892.
authors.forename: K
authors.initials: K
authors.lastname: Cornetta
authors.forename: R A
authors.initials: RA
authors.lastname: Morgan
authors.forename: W F
authors.initials: WF
authors.lastname: Anderson
mesh_terms: 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