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Allowing Innovative Stem Cell-Based Therapies Outside of Clinical Trials: Ethical and Policy Challenges
Article first published online: 21 JUN 2010
DOI: 10.1111/j.1748-720X.2010.00488.x
© 2010 American Society of Law, Medicine & Ethics, Inc.
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How to Cite
Hyun, I. (2010), Allowing Innovative Stem Cell-Based Therapies Outside of Clinical Trials: Ethical and Policy Challenges. The Journal of Law, Medicine & Ethics, 38: 277–285. doi: 10.1111/j.1748-720X.2010.00488.x
Publication History
- Issue published online: 21 JUN 2010
- Article first published online: 21 JUN 2010
- Abstract
- References
- Cited By
This paper discusses exceptional circumstances under which patients outside of clinical trials are likely to receive innovative stem cell-based interventions. These circumstances involve: (1) stem cell interventions not initially amenable to a clinical trials approach; (2) expanded access to investigational stem cell products (“compassionate use”); and (3) off-label uses of FDA approved stem cell products. This paper proposes a new approach to regulating these exceptional cases.