Commentary
Arthritis gene therapy's first death
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* Corresponding author: Christopher H Evans cevans@rics.bwh.harvard.edu
1 Center for Molecular Orthopaedics, Harvard Medical School, 221 Longwood Avenue, BLI-152, Boston, MA 02115, USA
2 Department of Orthopaedics and Rehabilitation, Florida University College of Medicine, 1600 SW Archer Road, MSB Room M2-210, FL 32610, USA
3 Department of Microbiology and Molecular Genetics, University of Pittsburgh School of Medicine, BST W1246, PA 15261, USA
Arthritis Research & Therapy 2008, 10:110 doi:10.1186/ar2411
Published: 27 May 2008Abstract
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.