Arthritis gene therapy's first death

Christopher H. Evans; Steven C. Ghivizzani; Paul D. Robbins

doi:10.1186/ar2411

Arthritis gene therapy's first death

Christopher H. Evans, Steven C. Ghivizzani, Paul D. Robbins

Physical Medicine and Rehabilitation

Research output: Contribution to journal › Article › peer-review

73 Scopus citations

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.

Original language	English (US)
Article number	110
Journal	Arthritis Research and Therapy
Volume	10
Issue number	3
DOIs	https://doi.org/10.1186/ar2411
State	Published - Feb 27 2008

ASJC Scopus subject areas

Rheumatology
Immunology and Allergy
Immunology

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10.1186/ar2411

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title = "Arthritis gene therapy's first death",

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.",

author = "Evans, {Christopher H.} and Ghivizzani, {Steven C.} and Robbins, {Paul D.}",

note = "Funding Information: The authors are very grateful to the subject{\textquoteright}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{\textquoteright} work in this area has been supported by National Institutes of Health grants DK 446640, AR 43623, AR47353-01, AR050249, AR048566 and AR051085.",

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AB - 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.

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Arthritis gene therapy's first death

Abstract

ASJC Scopus subject areas

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