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

Published version
Peer-reviewed

Type

Article

Change log

Authors

Barker, Roger A 
Carpenter, Melissa K 
Forbes, Stuart 
Goldman, Steven A 
Jamieson, Catriona 

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.

Description

Keywords

early phase clinical trials, guidelines, human stem cell-derived interventions, institutional review and ethics boards, review process, Clinical Trials as Topic, Ethics Committees, Research, Humans, Stem Cell Transplantation, Stem Cells, Surveys and Questionnaires, Translational Research, Biomedical

Journal Title

Stem Cell Reports

Conference Name

Journal ISSN

2213-6711
2213-6711

Volume Title

10

Publisher

Elsevier BV
Sponsorship
Medical Research Council (MC_PC_12009)