Arthritis gene therapy's first death.
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.
Evans
Christopher H
CH
Center for Molecular Orthopaedics, Harvard Medical School, 221 Longwood Avenue, BLI-152, Boston, MA 02115, USA. cevans@rics.bwh.harvard.edu
Ghivizzani
Steven C
SC
Robbins
Paul D
PD
D000328:Adult; D001168:Arthritis / Q000235:genetics* / Q000628:therapy*; D002986:Clinical Trials as Topic / Q000379:methods / Q000639:trends; D017809:Fatal Outcome; D005260:Female; D015316:Genetic Therapy / Q000009:adverse effects*; D006801:Humans