Key result
A 36-year-old woman with rheumatoid arthritis died from disseminated histoplasmosis and a retroperitoneal hematoma 22 days after receiving a second dose of the experimental gene therapy tgAAC94.
This article reviews the circumstances and regulatory response surrounding the first death in an arthritis gene therapy trial.
Gene therapy death prompted protocol scrutiny; leaves open long-term safety of arthritis gene therapy approaches.
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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Evans et al. (2008) conducted a review in Rheumatoid arthritis (n=127). tgAAC94 (AAV2-TNFR:Fc gene therapy) vs. Placebo was evaluated on Safety. A 36-year-old woman with rheumatoid arthritis died from disseminated histoplasmosis and a retroperitoneal hematoma 22 days after receiving a second dose of the experimental gene therapy tgAAC94.
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