Evans Christopher H, Ghivizzani Steven C, Robbins Paul D
Center for Molecular Orthopaedics, Harvard Medical School, 221 Longwood Avenue, BLI-152, Boston, MA 02115, USA.
Arthritis Res Ther. 2008;10(3):110. doi: 10.1186/ar2411. Epub 2008 May 27.
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.
2007年7月，一名受试者在参加一项关节炎基因治疗试验期间死亡。在对这起悲剧事件的相关情况进行调查时，该研究被暂停。2007年12月初，美国食品药品监督管理局解除了临床暂停，允许该研究在对方案进行微小改动后恢复。在本文中，我们整理了我们所能获得的关于这项临床试验的信息，并在关节炎基因治疗的更广泛背景下进行讨论。
