The Challenges of First-in-Human Stem Cell Clinical Trials: What Does This Mean for Ethics and Institutional Review Boards?

Roger A. Barker*, Melissa K. Carpenter, Stuart Forbes, Steven A. Goldman, Catriona Jamieson, Charles E. Murry, Jun Takahashi, Gordon Weir

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

Abstract

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.

Original languageEnglish
Pages (from-to)1429-1431
Number of pages3
JournalStem Cell Reports
Volume10
Issue number5
Early online date8 May 2018
DOIs
Publication statusE-pub ahead of print - 8 May 2018

Keywords

  • early phase clinical trials
  • guidelines
  • human stem cell-derived interventions
  • institutional review and ethics boards
  • review process

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