The Challenges of First-in-Human Stem Cell Clinical Trials: What Does This Mean for Ethics and Institutional Review Boards?

Roger A Barker; Melissa K Carpenter; Stuart Forbes; Steven A. Goldman; Catriona Jamieson; Charles E Murry; Jun Takahashi; Gordon Weir

doi:10.1016/j.stemcr.2018.04.010

The Challenges of First-in-Human Stem Cell Clinical Trials: What Does This Mean for Ethics and Institutional Review Boards?

Roger A Barker, Melissa K Carpenter, Stuart Forbes, Steven A. Goldman, Catriona Jamieson, Charles E Murry, Jun Takahashi, Gordon Weir

9 Citationer (Scopus)

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Abstract

Stem cell-based clinical interventions are increasingly advancing through preclinical testing and approaching clinical trials. The complexity and diversity of these approaches, and the confusion created by unproven and untested stem cell-based "therapies," create a growing need for a more comprehensive review of these early-stage human trials to ensure they place the patients at minimal risk of adverse events but are also based on solid evidence of preclinical efficacy with a clear scientific rationale for that effect. To address this issue and supplement the independent review process, especially that of the ethics and institutional review boards who may not be experts in stem cell biology, the International Society for Stem Cell Research (ISSCR) has developed a set of practical questions to cover the major issues for which clear evidence-based answers need to be obtained before approving a stem cell-based trial.

Originalsprog	Engelsk
Tidsskrift	Stem Cell Reports
Vol/bind	10
Udgave nummer	5
Sider (fra-til)	1429-1431
Antal sider	3
ISSN	2213-6711
DOI	https://doi.org/10.1016/j.stemcr.2018.04.010
Status	Udgivet - 8 maj 2018

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10.1016/j.stemcr.2018.04.010Licens: CC BY-NC-ND

1-s2.0-S2213671118301784-mainForlagets udgivne version, 254 KBLicens: CC BY-NC-ND

Citationsformater

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AU - Barker, Roger A

AU - Carpenter, Melissa K

AU - Forbes, Stuart

AU - Goldman, Steven A.

AU - Jamieson, Catriona

AU - Murry, Charles E

AU - Takahashi, Jun

AU - Weir, Gordon

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The Challenges of First-in-Human Stem Cell Clinical Trials: What Does This Mean for Ethics and Institutional Review Boards?

Abstract

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