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 wit...

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Detalles Bibliográficos
Autores principales: Evans, Christopher H, Ghivizzani, Steven C, Robbins, Paul D
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2008
Materias:
Commentary
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2483436/
https://www.ncbi.nlm.nih.gov/pubmed/18510784
http://dx.doi.org/10.1186/ar2411
Descripción
Sumario: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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