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.
|Original language||English (US)|
|Journal||Arthritis Research and Therapy|
|State||Published - Feb 27 2008|
Bibliographical noteFunding Information:
The authors are very grateful to the subject’s husband for giving his permission for this article to be submitted. The authors thank Dr Bartlett, Dr Crow, Dr Federoff, Dr Friedmann, Dr Hogarth, Dr Katz and Dr Lipsky for critiquing earlier drafts of this paper. The authors’ work in this area has been supported by National Institutes of Health grants DK 446640, AR 43623, AR47353-01, AR050249, AR048566 and AR051085.