Jesse Gelsinger

Jesse Gelsinger (June 18, 1981 – September 17, 1999) was an American teenager from Tucson, Arizona, who died as a result of participating in a gene therapy trial. His death led to significant changes in the regulation of clinical trials within the United States, highlighting the importance of ethical standards and participant safety in medical research. Gelsinger's case remains a pivotal moment in the history of biomedical ethics and gene therapy research.

Background[edit | edit source]

Jesse Gelsinger was diagnosed with ornithine transcarbamylase deficiency (OTCD), a rare metabolic disorder that affects the liver's ability to break down ammonia. Although Gelsinger managed his condition through diet and medication, he volunteered for a gene therapy trial aimed at testing a new treatment for OTCD. The trial was conducted at the University of Pennsylvania's Institute for Human Gene Therapy.

The Gene Therapy Trial[edit | edit source]

The trial involved the use of an adenovirus vector to deliver a corrected gene to the liver. On September 13, 1999, Gelsinger received an infusion of the adenoviral vector. However, he quickly developed a severe immune response to the virus, leading to multiple organ failure and brain death. Gelsinger passed away on September 17, 1999, four days after receiving the treatment.

Aftermath and Impact[edit | edit source]

Jesse Gelsinger's death sparked a national debate on the ethics of gene therapy research and the protection of clinical trial participants. Investigations revealed that the trial had several regulatory and ethical issues, including failure to adequately inform participants of the risks and previous adverse events in the trial. As a result, the U.S. Food and Drug Administration (FDA) temporarily halted all gene therapy trials at the University of Pennsylvania and implemented stricter regulations for clinical trials nationwide.

Legacy[edit | edit source]

The tragedy of Jesse Gelsinger's death brought about increased scrutiny and improved regulatory measures in clinical research to ensure the safety and informed consent of participants. It also raised awareness about the potential risks associated with gene therapy and the importance of ethical considerations in biomedical research. Gelsinger's case is often cited in discussions on medical ethics, patient rights, and the regulation of clinical trials.