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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