COMMENTARY - Arthritis gene therapy's first death

[Guest guest]

Arthritis Research & Therapy 2008, 10:110doi:10.1186/ar2411

Published: 27 May 2008

Commentary

Arthritis gene therapy's first death

H 1 , C Ghivizzani2 and D Robbins3

1Center for Molecular Orthopaedics, Harvard Medical School, 221

Longwood Avenue, BLI-152, Boston, MA 02115, USA

2Department of Orthopaedics and Rehabilitation, Florida University

College of Medicine, 1600 SW Archer Road, MSB Room M2-210, FL 32610,

USA

3Department of Microbiology and Molecular Genetics, University of

Pittsburgh School of Medicine, BST W1246, PA 15261, USA

Abstract

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.

****************************************************

Read the entire article here:

http://arthritis-research.com/content/10/3/110

--

Not an MD