Allowing Innovative Stem Cell-Based Therapies Outside of Clinical Trials: Ethical and Policy Challenges
Version of Record online: 21 JUN 2010
© 2010 American Society of Law, Medicine & Ethics, Inc.
The Journal of Law, Medicine & Ethics
Volume 38, Issue 2, pages 277–285, Summer 2010
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
- Issue online: 21 JUN 2010
- Version of Record online: 21 JUN 2010
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.