Teenager's death in gene therapy trial at Penn probably caused by massive reaction to protein used in study.
Researchers believe that the death of a teenager in a gene therapy trial at the University of Pennsylvania (body, education) University of Pennsylvania - The home of ENIAC and Machiavelli.
Address: Philadelphia, PA, USA. (Penn) was caused by a massive immune system immune system
Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. reaction associated with a protein used in the study.
Penn scientists said the protein, which coated the adenovirus adenovirus
Any of a group of spheroidal viruses, made up of DNA wrapped in a protein coat, that cause sore throat and fever in humans, hepatitis in dogs, and several diseases in fowl, mice, cattle, pigs, and monkeys. used to carry new genes into 18-year-old Jesse Gelsinger's damaged liver, triggered an immune system response which ultimately led to coma and organ failure. Tests in monkeys confirmed this chain of events.
Gelsinger's death in September 1999,the first known to have been caused by gene therapy, resulted in a lawsuit against the university and prompted the FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. to indefinitely suspend Penn's gene therapy trials last March. In addition, James Wilson, MD, director of the Philadelphia university's Institute for Human Gene Therapy, faces an FDA action that aims to bar him from ever conducting another human trial in the United States. Wilson also was accused of having a conflict of interest because a company he established funded part of the research.
Wilson declined comment on the new findings until they are published in a medical journal. But he discussed them at a closed-door medical meeting attended by several hundred gene therapy researchers earlier this month in Snowbird snowbird: see junco. , UT. Some attendees confirmed the findings to The Philadelphia Inquirer.
Donald Kohn of the University of Southern California The U.S. News & World Report ranked USC 27th among all universities in the United States in its 2008 ranking of "America's Best Colleges", also designating it as one of the "most selective universities" for admitting 8,634 of the almost 34,000 who applied for freshman admission said the results call into question the safety of newer viral vectors. Unlike older adenovirus vectors, which had only a portion of their viral genes removed, viral genes are completely extracted from the new "gutted adenoviruses." These vectors do, however, retain the protein coats that have been implicated im·pli·cate
tr.v. im·pli·cat·ed, im·pli·cat·ing, im·pli·cates
1. To involve or connect intimately or incriminatingly: evidence that implicates others in the plot.
2. in Gelsinger's death. "If you give huge amounts [of gutted adenoviral vector], it may be a problem," Kohn said.
An attorney representing the family of Gelsinger expressed disappointment at the findings. In November, the family settled a wrongful death lawsuit with Penn for an undisclosed sum. "What Dr. Wilson also seems to have confirmed is that this clinical trial should never have started," Alan Milstein said.