Arthritis Gene Therapy's First Death

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.

Publication types

  • Case Reports
  • Editorial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Arthritis / genetics*
  • Arthritis / therapy*
  • Clinical Trials as Topic / methods
  • Clinical Trials as Topic / trends
  • Fatal Outcome
  • Female
  • Genetic Therapy / adverse effects*
  • Humans