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carrying a corrected gene to test the safety of the procedure. He died four days later at the age of 18, on
September 17, apparently having suffered a massive immune response triggered by the use of the viral vector to transport the gene into his cells, leading to multiple organ failure and brain
107:
The
University of Pennsylvania later issued a rebuttal, but the university and Children's National Medical Center each agreed to pay more than $ 500,000 to the government. Both Wilson and the University are reported to have had financial stakes in the research. After his death, all gene therapy
57:
breakdown. The disease is usually fatal at birth, but
Gelsinger had a milder form of the disease, in which the ornithine transcarbamylase gene is mutated in only part of the patient's cells, a condition known as
834:
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trials in the United States halted for a time. The
Gelsinger case was a severe setback for scientists working in the field and a reminder of the risks involved.
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that aimed at developing a treatment for infants born with the severe form of the disease. On
September 13, 1999, Gelsinger was injected with
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30:(June 18, 1981 – September 17, 1999) was the first person publicly identified as having died in a clinical trial for
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Inclusion of
Gelsinger as a substitute for another volunteer who dropped out, despite Gelsinger's having high
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Failure to disclose, in the informed-consent documentation, the deaths of monkeys given a similar treatment.
62:. As his deficiency was partial, Gelsinger managed to survive on a restricted diet and special medications.
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81:(FDA) investigation concluded that the scientists involved in the trial, including the co-investigator
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85:(Director of the Institute for Human Gene Therapy), broke several rules of conduct:
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https://www.fda.gov/regulatoryinformation/foi/electronicreadingroom/ucm144564.htm
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http://blog.bioethics.net/2008/01/on-gene-therapy-and-informed-consent/#comments
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Branca, MA (May 2005). "Gene therapy: cursed or inching towards credibility?".
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Failure by the university to report that two patients had experienced serious
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151:"Institute for Human Gene Therapy Responds to FDA – Almanac Between Issues"
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Science for Sale. The Perils, Rewards, and
Delusions of Campus Capitalism
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228:"Don't Compromise Ethics in Human Experiments, Bioethics Expert Says"
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BBC Horizon Trial and error – the rise and fall of genome therapy:
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https://www.wired.com/1999/10/another-chance-for-gene-therapy/
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levels that should have led to his exclusion from the trial.
49:, the symptoms of which include an inability to metabolize
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http://www.bbc.co.uk/science/horizon/2003/trialerror.shtml
217:. Chicago: U. Chicago Press, 2007, 324pp., pages 104–106.
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Greenberg v. Miami
Children's Hospital Research Institute
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American man who died during a clinical trial (1981–1999)
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Paul
Gelsinger, Jesse's father, tells of Jesse's death:
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On gene therapy and informed consent (2008 debate):
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773:Moore v. Regents of the University of California
347:http://www.guineapigzero.com/jesses-intent.html
230:. Law.virginia.edu. 2008-04-18. Archived from
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65:Gelsinger joined a clinical trial run by the
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688:Schloendorff v. Society of New York Hospital
877:Human subject research in the United States
784:Medical Experimentation on Black Americans
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124:Stolberg, Sheryl Gay (November 28, 1999).
722:Albert Kligman's dermatology experiments
779:Surgery to try to improve mental health
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126:"The Biotech Death of Jesse Gelsinger"
36:ornithine transcarbamylase deficiency
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339:Another Chance For Gene Therapy?:
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288:(5928). Sciencemag.org: 727–728.
278:"A History Lesson for Stem Cells"
555:Betancourt v. Trinitas Hospital
276:Wilson, James M. (2009-05-08).
799:Radioactive iodine experiments
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742:Guatemala syphilis experiment
253:"Challenges in Gene Therapy"
79:Food and Drug Administration
752:Human radiation experiments
130:The New York Times Magazine
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809:Stanford prison experiment
67:University of Pennsylvania
34:. Gelsinger suffered from
711:Abdullahi v. Pfizer, Inc.
562:Commonwealth v. Twitchell
419:Betty and George Coumbias
872:History of biotechnology
867:Clinical trial disasters
829:Willowbrook State School
824:Tuskegee Syphilis Study
767:Joseph Gilbert Hamilton
546:parent/patient/guardian
544:Medical opinion against
302:10.1126/science.1174935
153:. Upenn.edu. 2000-02-14
585:Archie Battersbee case
100:from the gene therapy.
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804:Skid Row Cancer Study
640:Spiro Nikolouzos case
625:Joseph Maraachli case
213:Greenberg, Daniel S.
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819:Plutonium injections
401:Medical ethics cases
173:Nature Biotechnology
71:an adenoviral vector
645:Aruna Shanbaug case
568:Mordechai Dov Brody
294:2009Sci...324..727W
185:10.1038/nbt0505-519
789:Milgram experiment
732:Deep sleep therapy
694:Christiane Völling
675:Gillick competence
257:University of Utah
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595:Tirhas Habtegiris
590:Charlie Gard case
524:Karen Ann Quinlan
444:Piergiorgio Welby
60:somatic mosaicism
53:– a byproduct of
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670:Ashley Treatment
660:Informed consent
630:Jahi McMath case
580:Alfie Evans case
574:Lantz v. Coleman
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635:Sarah Murnaghan
615:Ashya King case
605:Sun Hudson case
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43:genetic disease
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23:Jesse Gelsinger
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663:to treatment
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499:June Hartley
489:Baby Doe Law
321:. Retrieved
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260:. Retrieved
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236:. Retrieved
232:the original
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155:. Retrieved
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133:. Retrieved
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98:side effects
83:James Wilson
76:
64:
32:gene therapy
27:
26:
862:1999 deaths
857:1981 births
479:Paul Brophy
460:Withholding
458:Euthanasia/
851:Categories
600:Rom Houben
484:Carol Carr
474:Tony Bland
424:Dax Cowart
323:2012-02-29
262:2020-11-02
238:2010-11-16
157:2010-11-16
814:Study 329
462:treatment
409:Assisted
318:206520573
703:Research
310:19423804
193:15877060
40:X-linked
411:suicide
290:Bibcode
282:Science
201:6628811
135:July 5,
91:ammonia
74:death.
55:protein
51:ammonia
45:of the
610:Baby K
514:Baby M
316:
308:
199:
191:
314:S2CID
197:S2CID
112:Notes
47:liver
38:, an
306:PMID
189:PMID
137:2018
298:doi
286:324
181:doi
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