The Challenges of First-in-Human Stem Cell Clinical Trials

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

Research output: Contribution to journal › Comment/debate › Communication

Standard

The Challenges of First-in-Human Stem Cell Clinical Trials : What Does This Mean for Ethics and Institutional Review Boards? / Barker, Roger A; Carpenter, Melissa K; Forbes, Stuart; Goldman, Steven A.; Jamieson, Catriona; Murry, Charles E; Takahashi, Jun; Weir, Gordon.

In: Stem Cell Reports, Vol. 10, No. 5, 08.05.2018, p. 1429-1431.

Research output: Contribution to journal › Comment/debate › Communication

Harvard

Barker, RA, Carpenter, MK, Forbes, S, Goldman, SA, Jamieson, C, Murry, CE, Takahashi, J & Weir, G 2018, 'The Challenges of First-in-Human Stem Cell Clinical Trials: What Does This Mean for Ethics and Institutional Review Boards?', Stem Cell Reports, vol. 10, no. 5, pp. 1429-1431. https://doi.org/10.1016/j.stemcr.2018.04.010

APA

Barker, R. A., Carpenter, M. K., Forbes, S., Goldman, S. A., Jamieson, C., Murry, C. E., Takahashi, J., & Weir, G. (2018). The Challenges of First-in-Human Stem Cell Clinical Trials: What Does This Mean for Ethics and Institutional Review Boards? Stem Cell Reports, 10(5), 1429-1431. https://doi.org/10.1016/j.stemcr.2018.04.010

Vancouver

Barker RA, Carpenter MK, Forbes S, Goldman SA, Jamieson C, Murry CE et al. The Challenges of First-in-Human Stem Cell Clinical Trials: What Does This Mean for Ethics and Institutional Review Boards? Stem Cell Reports. 2018 May 8;10(5):1429-1431. https://doi.org/10.1016/j.stemcr.2018.04.010

Author

Barker, Roger A ; Carpenter, Melissa K ; Forbes, Stuart ; Goldman, Steven A. ; Jamieson, Catriona ; Murry, Charles E ; Takahashi, Jun ; Weir, Gordon. / The Challenges of First-in-Human Stem Cell Clinical Trials : What Does This Mean for Ethics and Institutional Review Boards?. In: Stem Cell Reports. 2018 ; Vol. 10, No. 5. pp. 1429-1431.

Bibtex

@article{be16f8bd22e44bea8b884ed5822a278c,

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

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.",

author = "Barker, {Roger A} and Carpenter, {Melissa K} and Stuart Forbes and Goldman, {Steven A.} and Catriona Jamieson and Murry, {Charles E} and Jun Takahashi and Gordon Weir",

year = "2018",

month = may,

day = "8",

doi = "10.1016/j.stemcr.2018.04.010",

language = "English",

volume = "10",

pages = "1429--1431",

journal = "Stem Cell Reports",

issn = "2213-6711",

publisher = "Cell Press",

number = "5",

}

RIS

TY - JOUR

T1 - The Challenges of First-in-Human Stem Cell Clinical Trials

T2 - What Does This Mean for Ethics and Institutional Review Boards?

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

PY - 2018/5/8

Y1 - 2018/5/8

N2 - 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.

AB - 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.

U2 - 10.1016/j.stemcr.2018.04.010

DO - 10.1016/j.stemcr.2018.04.010

M3 - Comment/debate

C2 - 29742388

VL - 10

SP - 1429

EP - 1431

JO - Stem Cell Reports

JF - Stem Cell Reports

SN - 2213-6711

IS - 5

ER -

ID: 203407016

Center for Translational Neuromedicine