Abstract
SummaryWe 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.
Highlights
The therapeutic promise of stem cell interventions has led to substantial international investment in research and clinical translation (Aging Analytics Agency, 2014; Caulfield et al, 2010)
While most clinical trials of stem cell interventions remain focused on malignant and benign hematopoietic disorders, for which stem cell transplantation has been the standard of care for decades (Rettig et al, 2007), innovative but as yet unproven therapies are in clinical development (Heathman et al, 2015; Li et al, 2014; Trounson and McDonald, 2015), and a small number have received regulatory approval
Advances in stem cell research have raised the expectations of policy makers, funders, patients, and the public, but there is a large gap between expectations and clinical realities (Bubela et al, 2012)
Summary
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. 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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