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ArtikelInvestigation of the Cause of Death in a Gene-Therapy Trial  
Oleh: Frank, Karen M. ; Hogarth, D. Kyle ; Miller, Jonathan L. ; Mandal, Saptarshi
Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: The New England Journal of Medicine (keterangan: ada di Proquest) vol. 361 no. 02 (Jul. 2009), page 161-169.
Topik: Gene-Therapy Trial
Ketersediaan
  • Perpustakaan FK
    • Nomor Panggil: N08.K.2009.04
    • Non-tandon: 1 (dapat dipinjam: 0)
    • Tandon: tidak ada
    Lihat Detail Induk
Isi artikelWe present a case of disseminated histoplasmosis, complicated by retroperitoneal bleeding and leading to death, in a patient who was receiving systemic immunosuppressive therapy for rheumatoid arthritis and who was enrolled in a gene-therapy trial. This trial was designed to evaluate intraarticular delivery of a tumor necrosis factor {alpha} (TNF-{alpha}) antagonist, through an adeno-associated virus (AAV) type 2 delivery system, for inflammatory arthritis. The patient's receipt of concurrent anti–TNF-{alpha} therapy and other immunosuppressive therapy while she was living in an area where histoplasmosis was endemic was thought to be the most likely explanation for the infection; the evidence presented suggests that this fatal infection was unlikely to have been related to exposure to the agent administered in the gene-therapy trial. This case reinforces the importance of considering infectious complications, such as those from endemic mycoses, in patients receiving treatment with a TNF-{alpha} antagonist and the importance of having a well-designed monitoring plan when subjects in a research study become ill.
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