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Báo cáo y học: "Arthritis gene therapy’s first death"

Tuyển tập các báo cáo nghiên cứu về y học được đăng trên tạp chí y học General Psychiatry cung cấp cho các bạn kiến thức về ngành y đề tài: Arthritis gene therapy’s first death. | Available online http arthritis-research.eom content 10 3 110 Commentary Arthritis gene therapy s first death Christopher H Evans1 Steven C Ghivizzani2 and Paul D Robbins3 1 Center for Molecular Orthopaedics Harvard Medical School 221 Longwood Avenue BLI-152 Boston MA 02115 USA 2Department of Orthopaedics and Rehabilitation Florida University College of Medicine 1600 SW Archer Road MSB Room M2-210 FL 32610 USA 3Department of Microbiology and Molecular Genetics University of Pittsburgh School of Medicine BST W1246 PA 15261 USA Corresponding author Christopher H Evans cevans@rics.bwh.harvard.edu Published 27 May 2008 This article is online at http arthritis-research.com content 10 3 110 2008 BioMed Central Ltd Arthritis Research Therapy 2008 10 110 doi 10.1186 ar2411 Abstract In July 2007 a subject died while enrolled in an arthritis gene therapy trial. The study was placed on clinical hold while the circumstances surrounding this tragedy were investigated. Early in December 2007 the Food and Drug Administration removed the clinical hold allowing the study to resume with minor changes to the protocol. In the present article we collate the information we were able to obtain about this clinical trial and discuss it in the wider context of arthritis gene therapy. Introduction On 24 July 2007 a 36-year-old woman with rheumatoid arthritis RA died 22 days after receiving a second dose of an experimental arthritis gene therapeutic 1 . The Food and Drug Administration FDA placed the trial on hold while the circumstances of the participant s death were investigated the National Institutes of Health Recombinant DNA Advisory Committee RAC launched a similar enquiry. At the beginning of December 2007 the FDA allowed the trial to proceed suggesting that it did not attribute the subject s death to the gene treatment. A few days later however the RAC concluded that a possible role of the gene transfer in this clinical course cannot definitively be excluded due to the lack of data .