UCSF: Federal Government Halts Three Gene Therapy Trials
Federal investigators have suspended three gene therapy trials at the UC-San Francisco because the testing was part of the same study in which patient Jesse Gelsinger died at the University of Pennsylvania, the San Jose Mercury News reports. The FDA suspended two of the UCSF trials, while the NIH suspended the third. Sue Shafer, assistant vice chancellor for research affairs at UCSF, said, "Everything that has been suspended (at UCSF) has been directly or indirectly related to the Penn fatality. ... It has a ripple effect. They used related vectors -- that's why they were put on hold." Twenty-six of the 48 patients involved in UCSF's nine gene therapy trials have died, although "none of the deaths is thought to be due to the experiment." The government is reviewing additional experiments at San Francisco Medical Center, as well as other trials that used adenovirus, a genetically modified virus used as a vehicle to deliver new genes. Four gene therapy trials at Stanford Medical Center will continue because they are not connected to the UPenn trial. In the meantime, investigators are attempting to explain what caused Gelsinger's immune system to react so violently to the therapy. James Wilson, director of the Institute for Human Gene Therapy at UCSF, said, "The vector provoked an immediate immune response, or inflammation, a widespread inflammation that was out of control and eventually led to the failure of his lungs and then the demise of his other organs. What we are trying to understand is, what is it from the vector that initiated this inflammatory response?" (Krieger, 2/15).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.