Response to Frederic Bretzner et al. “Target Populations for First-In-Human Embryonic Stem Cell Research in Spinal Cord Injury”

We address concerns raised in this issue by Bretzner et al. (2011) by explaining the rationale for including subjects with subacute, neurologically complete spinal cord injuries in the Phase 1 trial of GRNOPC1. We also present elements of the informed consent process that minimize the likelihood of...

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Bibliographic Details
Published inCell stem cell Vol. 8; no. 5; pp. 476 - 478
Main Authors Wirth, Edward, Lebkowski, Jane S., Lebacqz, Karen
Format Journal Article
LanguageEnglish
Published United States Elsevier Inc 06.05.2011
Subjects
Animals
Biomedical Research
Clinical Trials, Phase I as Topic
Consent Forms - ethics
Consent Forms - legislation & jurisprudence
Health Care Rationing
Humans
Knowledge Bases
Models, Animal
Patient Rights
Patient Selection - ethics
Recovery of Function
Risk Assessment
Spinal Cord Injuries - epidemiology
Spinal Cord Injuries - therapy
Treatment Outcome
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Summary:We address concerns raised in this issue by Bretzner et al. (2011) by explaining the rationale for including subjects with subacute, neurologically complete spinal cord injuries in the Phase 1 trial of GRNOPC1. We also present elements of the informed consent process that minimize the likelihood of therapeutic misconception.
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ISSN:1934-5909
1875-9777
DOI:10.1016/j.stem.2011.04.008