Allowing innovative stem cell-based therapies outside of clinical trials: ethical and policy challenges.
The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics 2010 Summer; 38(2): 277-85
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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Review of K.R. Monroe, R.B. Miller, and J. Tobis. Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical and Political Issues; Review of C.B. Cohen. Renewing the Stuff of Life: Stem Cells, Ethics, and Public Policy; Review of R. Korobkin with S.R. Munzer. Stem Cell Century: Law and Policy for a Breakthrough Technology Hyun, Insoo (2008-06)