Allowing Innovative Stem Cell-Based Therapies Outside of Clinical Trials: Ethical and Policy Challenges

Journal of Law, Medicine and Ethics 38 (2):277-285 (2010)
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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



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Insoo Hyun
Case Western Reserve University

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Ethics and innovation in medicine.George J. Agich - 2001 - Journal of Medical Ethics 27 (5):295-296.

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