The Challenges of First-in-Human Stem Cell Clinical Trials: What Does This Mean for Ethics and Institutional Review Boards?
Carpenter, Melissa K
Murry, Charles E
Stem cell reports
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Barker, R., Carpenter, M. K., Forbes, S., Goldman, S. A., Jamieson, C., Murry, C. E., Takahashi, J., & et al. (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
Stem cell-based clinical interventions are increasingly advancing through pre-clinical testing and approaching clinical trials. The complexity and diversity of these approaches, and the confusion created by unproven and untested stem cell-based “therapies,” creates 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 / 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.
Stem Cells, Humans, Stem Cell Transplantation, Ethics Committees, Research, Clinical Trials as Topic, Translational Medical Research, Surveys and Questionnaires
External DOI: https://doi.org/10.1016/j.stemcr.2018.04.010
This record's URL: https://www.repository.cam.ac.uk/handle/1810/278624
Attribution-NonCommercial-NoDerivatives 4.0 International
Licence URL: http://creativecommons.org/licenses/by-nc-nd/4.0/
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