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'''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.
{{Short description|Overview of Jesse Gelsinger's case in gene therapy}}


==Background==
== Jesse Gelsinger ==
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.
[[File:JesseGelsingerROIsmall.tif|thumb|right|Jesse Gelsinger]]
Jesse Gelsinger was an American teenager who became widely known for his involvement in a clinical trial for gene therapy that resulted in his death. His case is often cited in discussions about the ethics and safety of [[gene therapy]] and [[clinical trials]].


==The Gene Therapy Trial==
=== Early Life ===
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.
Jesse Gelsinger was born in 1981 and was diagnosed with a genetic disorder known as [[ornithine transcarbamylase deficiency]] (OTCD), a rare metabolic disorder that affects the liver's ability to eliminate ammonia from the bloodstream. Unlike many with the condition, Jesse's form was mild, allowing him to lead a relatively normal life with dietary restrictions and medication.


==Aftermath and Impact==
=== The Clinical Trial ===
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.
In 1999, Jesse Gelsinger participated in a clinical trial at the [[University of Pennsylvania]] aimed at treating OTCD through gene therapy. The trial was led by Dr. [[James M. Wilson]], a prominent researcher in the field. The therapy involved injecting an adenoviral vector carrying a corrected gene into the liver.


==Legacy==
=== The Incident ===
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.
On September 13, 1999, Jesse received the gene therapy treatment. Shortly after the administration, he experienced a severe immune response, leading to multiple organ failure and brain death. Jesse Gelsinger died four days later, on September 17, 1999.


==See Also==
=== Impact and Controversy ===
Jesse Gelsinger's death had a profound impact on the field of gene therapy. It raised significant ethical questions about the conduct of clinical trials, informed consent, and the oversight of experimental treatments. The incident led to increased scrutiny of gene therapy trials and regulatory changes by the [[Food and Drug Administration]] (FDA).
 
The case also highlighted issues related to conflicts of interest, as it was revealed that Dr. Wilson held a financial stake in the company developing the therapy. This raised concerns about the potential for bias in the trial's design and execution.
 
== Legacy ==
Jesse Gelsinger's case remains a pivotal moment in the history of gene therapy. It serves as a cautionary tale about the risks of experimental treatments and the importance of ethical standards in medical research. The lessons learned from this incident continue to influence the development and regulation of gene therapies today.
 
== Related Pages ==
* [[Gene therapy]]
* [[Gene therapy]]
* [[Clinical trial]]
* [[Clinical trial]]
* [[Biomedical ethics]]
* [[Ornithine transcarbamylase deficiency]]
* [[Ornithine transcarbamylase deficiency]]
* [[Adenovirus]]
* [[James M. Wilson]]
* [[Food and Drug Administration]]


[[Category:1999 deaths]]
[[Category:Gene therapy]]
[[Category:Gene therapy]]
[[Category:Clinical trials]]
[[Category:Clinical trials]]
[[Category:Biomedical ethics]]
[[Category:Medical ethics]]
{{medicine-stub}}
[[Category:1970s births]]
[[Category:1999 deaths]]

Latest revision as of 05:33, 16 February 2025

Overview of Jesse Gelsinger's case in gene therapy


Jesse Gelsinger[edit]

File:JesseGelsingerROIsmall.tif
Jesse Gelsinger

Jesse Gelsinger was an American teenager who became widely known for his involvement in a clinical trial for gene therapy that resulted in his death. His case is often cited in discussions about the ethics and safety of gene therapy and clinical trials.

Early Life[edit]

Jesse Gelsinger was born in 1981 and was diagnosed with a genetic disorder known as ornithine transcarbamylase deficiency (OTCD), a rare metabolic disorder that affects the liver's ability to eliminate ammonia from the bloodstream. Unlike many with the condition, Jesse's form was mild, allowing him to lead a relatively normal life with dietary restrictions and medication.

The Clinical Trial[edit]

In 1999, Jesse Gelsinger participated in a clinical trial at the University of Pennsylvania aimed at treating OTCD through gene therapy. The trial was led by Dr. James M. Wilson, a prominent researcher in the field. The therapy involved injecting an adenoviral vector carrying a corrected gene into the liver.

The Incident[edit]

On September 13, 1999, Jesse received the gene therapy treatment. Shortly after the administration, he experienced a severe immune response, leading to multiple organ failure and brain death. Jesse Gelsinger died four days later, on September 17, 1999.

Impact and Controversy[edit]

Jesse Gelsinger's death had a profound impact on the field of gene therapy. It raised significant ethical questions about the conduct of clinical trials, informed consent, and the oversight of experimental treatments. The incident led to increased scrutiny of gene therapy trials and regulatory changes by the Food and Drug Administration (FDA).

The case also highlighted issues related to conflicts of interest, as it was revealed that Dr. Wilson held a financial stake in the company developing the therapy. This raised concerns about the potential for bias in the trial's design and execution.

Legacy[edit]

Jesse Gelsinger's case remains a pivotal moment in the history of gene therapy. It serves as a cautionary tale about the risks of experimental treatments and the importance of ethical standards in medical research. The lessons learned from this incident continue to influence the development and regulation of gene therapies today.

Related Pages[edit]