Academic Journal
The Challenges of First-in-Human Stem Cell Clinical Trials: What Does This Mean for Ethics and Institutional Review Boards?
| Title: | The Challenges of First-in-Human Stem Cell Clinical Trials: What Does This Mean for Ethics and Institutional Review Boards? |
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| Authors: | Roger A. Barker, Melissa K. Carpenter, Stuart Forbes, Steven A. Goldman, Catriona Jamieson, Charles E. Murry, Jun Takahashi, Gordon Weir |
| Source: | Stem Cell Reports, Vol 10, Iss 5, Pp 1429-1431 (2018) |
| Publisher Information: | Elsevier, 2018. |
| Publication Year: | 2018 |
| Collection: | LCC:Medicine (General) LCC:Biology (General) |
| Subject Terms: | Medicine (General), R5-920, Biology (General), QH301-705.5 |
| More Details: | 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. Keywords: human stem cell-derived interventions, early phase clinical trials, institutional review and ethics boards, review process, guidelines |
| Document Type: | article |
| File Description: | electronic resource |
| Language: | English |
| ISSN: | 2213-6711 |
| Relation: | http://www.sciencedirect.com/science/article/pii/S2213671118301784; https://doaj.org/toc/2213-6711 |
| DOI: | 10.1016/j.stemcr.2018.04.010 |
| Access URL: | https://doaj.org/article/4f9e4cdfc8644d40939fc6a548c620ec |
| Accession Number: | edsdoj.4f9e4cdfc8644d40939fc6a548c620ec |
| Database: | Directory of Open Access Journals |
| ISSN: | 22136711 |
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| DOI: | 10.1016/j.stemcr.2018.04.010 |
| Published in: | Stem Cell Reports |
| Language: | English |