期刊
STEM CELL REPORTS
卷 8, 期 5, 页码 1190-1201出版社
CELL PRESS
DOI: 10.1016/j.stemcr.2017.03.013
关键词
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资金
- Stem Cell Network Core Strategic Grant: Public Policy ELSI
- Genome Canada
- Genome Alberta
- Genome Quebec
- Canadian Institutes for Health Research (CIHR)
- Alberta Innovates - Health Solutions (AIHS)
- Canadian Stem Cell Network
- Alberta
- Quebec
- CIHR
- AIHS
We assessed the extent to which the publication of clinical trial results of innovative cell-based interventions reflects International Society for Stem Cell Research best practice guidelines. We assessed: (1) characteristics and time to publication of completed trials; (2) quality of reported trials; and (3) results of published trials. We identified and analyzed publications from 1,052 novel stem cell clinical trials: 179 (45.4%) of 393 completed trials had published results; 48 trials were registered by known stem cell tourism clinics, none of which reported results. Completed non-industry-sponsored trials initially published more rapidly, but differences with industry-sponsored trials decreased over time. Most publications reported safety, and 67.3% (mainly early-stage trials) reported positive outcomes. A higher proportion of industry trials reported positive efficacy. Heightened patient expectations for stem cell therapies give rise to ethical obligations for the transparent conduct of clinical trials. Reporting guidelines need to be developed that are specific to early-phase clinical trials.
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