Responsible Translation of Stem Cell Research: An Assessment of Clinical Trial Registration and Publications

• Main Authors: Moses Fung, Yan Yuan, Harold Atkins, Qian Shi, Tania Bubela
• Format: Article
• Language: English
• Published: Elsevier 2017-05-01
• Series: Stem Cell Reports
• Subjects: stem cell; clinical trial; clinical translation; clinical trial registry; clinical trial publication; stem cell tourism
• Online Access: http://www.sciencedirect.com/science/article/pii/S2213671117301194

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.