Event

The Gelsinger gene therapy trial

Phase I gene therapy trial at the University of Pennsylvania in which Jesse Gelsinger, 18, died on 17 September 1999.

5 links, 3 backed by primary records

Play the story Explore connections

Dates: 13–17 Sep 1999

Connections 5

involved

James M. Wilson led the trial Scholarship & press 1 2 3 4
The FDA wrote to him on 30 November 2000 and rejected his written explanation in 2002, as the Daily Pennsylvanian reported. He denied that money drove his research.
University of Pennsylvania ran the study; its institute answered the FDA in February 2000 Primary record 5 6
Genovo named with Wilson in the consent form as having a financial interest Scholarship & press 7
U.S. Department of Justice reached civil settlements in 2005 Primary record 5
U.S. Department of Health and Human Services its Office of Inspector General helped investigate Primary record 5

Timeline 1 date

13–17 Sep 1999 The Gelsinger gene therapy trial

Proof 7 sources

Death but one unintended consequence of gene-therapy trial, CMAJ, 2001. Scholarship & press
He was considered an ideal candidate for the trial, led by Dr. James Wilson, director of the Institute for Human Gene Therapy at the University of Pennsylvania.
Wilson may lose research ability, The Daily Pennsylvanian, 14 Dec 2000. Scholarship & press
In its letter to Wilson, the FDA concluded that Wilson “failed to adequately protect the safety and welfare of subjects” and that he “submitted misleading and inaccurate statements” to Penn’s review board.
Gene therapy: An Interview with an Unfortunate Pioneer, Scientific American, 1 Sep 2009. Scholarship & press
Wilson now believes that the teen died from a rare phenomenon called antibody-dependent enhancement.
Wilson admits, however, that there is no way to prove it, because none of Gelsinger’s pretreatment blood samples remain.
Wilson explanation rejected by FDA, The Daily Pennsylvanian, 11 Feb 2002. Scholarship & press
The Food and Drug Administration has rejected Institue for Human Gene Therapy Director James M. Wilson's letter of explanation
U.S. Settles Case of Gene Therapy Study That Ended With Teen's Death (U.S. Attorney's release of 9 February 2005, reprinted in Almanac), University of Pennsylvania Almanac, 15 Feb 2005. Primary record
stemming from a University of Pennsylvania gene therapy study that ended with the death of a participant, Arizona teenager Jesse Gelsinger.
the government has reached civil settlements stemming from a University of Pennsylvania gene therapy study that ended with the death of a participant
The case was investigated by the FDA’s Office of Criminal Investigations and the HHS-Office of Inspector General.
Institute for Human Gene Therapy Responds to FDA (Almanac Between Issues, 14 February 2000), University of Pennsylvania Almanac, 14 Feb 2000. Primary record
The record demonstrates that each and every patient who participated in the OTCD trial gave informed consent to participate.
Ethical Considerations in Phase I studies: Gelsinger Case, HarvardX (Harvard T.H. Chan School of Public Health), course case study. Scholarship & press
Please be aware that Dr. James M. Wilson and Genovo Inc. have a financial interest in a successful outcome from the research involved in this study.

Page history 1 change

2026-11-02Add 55 stories, each checked against its sourcesAlibek96e92fe6

Something wrong or missing? Tell us, with a source, or edit this page.