BioCentury
ARTICLE | Top Story

More sloppy gene therapy work

February 11, 2000 8:00 AM UTC

Washington -- Researchers at St. Jude Children's Research Hospital failed to conduct government-mandated safety checks on an adenoviral vector and may have exposed patients in two clinical trials to HIV and hepatitis C viruses, according to an FDA official and Baylor College of Medicine, which used vectors provided by St. Jude. The error is likely to hasten calls for more regulation of gene therapy trials.

The vector was used in two trials, a Phase I trial conducted by Baylor in cancer and a Phase I trial by St. Jude in neuroblastoma sponsored by the National Cancer Institute. Both used vector provided by St. Jude. The Baylor trial has been temporarily suspended. ...