Arthritis gene therapy's first death

被引:64
作者
Evans, Christopher H. [1 ]
Ghivizzani, Steven C. [2 ]
Robbins, Paul D. [3 ]
机构
[1] Harvard Univ, Sch Med, Ctr Mol Orthopaed, Boston, MA 02115 USA
[2] Univ Florida, Coll Med, Dept Orthopaed & Rehabil, Gainesville, FL 32610 USA
[3] Univ Pittsburgh, Sch Med, Dept Microbiol & Mol Genet, Pittsburgh, PA 15261 USA
基金
美国国家卫生研究院;
关键词
D O I
10.1186/ar2411
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
引用
收藏
页数:9
相关论文
共 36 条
[1]  
[Anonymous], 2006, J GENE MED, V8, P1435
[2]   GENE-TRANSFER TO SYNOVIOCYTES - PROSPECTS FOR GENE TREATMENT OF ARTHRITIS [J].
BANDARA, G ;
ROBBINS, PD ;
GEORGESCU, HI ;
MUELLER, GM ;
GLORIOSO, JC ;
EVANS, CH .
DNA AND CELL BIOLOGY, 1992, 11 (03) :227-231
[3]   Retroviral vectors:: new applications for an old tool [J].
Barquinero, J ;
Eixarch, H ;
Pérez-Melgosa, M .
GENE THERAPY, 2004, 11 (Suppl 1) :S3-S9
[4]   Retroviral integration and human gene therapy [J].
Bushman, Frederic D. .
JOURNAL OF CLINICAL INVESTIGATION, 2007, 117 (08) :2083-2086
[5]   Gene therapy of human severe combined immunodeficiency (SCID)-X1 disease [J].
Cavazzana-Calvo, M ;
Hacein-Bey, S ;
Basile, CD ;
Gross, F ;
Yvon, E ;
Nusbaum, P ;
Selz, F ;
Hue, C ;
Certain, S ;
Casanova, JL ;
Bousso, P ;
Le Deist, F ;
Fischer, A .
SCIENCE, 2000, 288 (5466) :669-672
[6]   Gene therapy clinical trials worldwide to 2007 - an update [J].
Edelstein, Michael L. ;
Abedi, Mohammad R. ;
Wixon, Jo .
JOURNAL OF GENE MEDICINE, 2007, 9 (10) :833-842
[7]  
Erles K, 1999, J MED VIROL, V59, P406, DOI 10.1002/(SICI)1096-9071(199911)59:3&lt
[8]  
406::AID-JMV22&gt
[9]  
3.0.CO
[10]  
2-N