期刊
STEM CELL REPORTS
卷 10, 期 5, 页码 1429-1431出版社
CELL PRESS
DOI: 10.1016/j.stemcr.2018.04.010
关键词
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资金
- Medical Research Council [MC_PC_12009] Funding Source: Medline
- NIMH NIH HHS [R01 MH099578, R01 MH104701] Funding Source: Medline
- NINDS NIH HHS [R01 NS110776] Funding Source: Medline
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.
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