Journal
JOURNAL OF LAW MEDICINE & ETHICS
Volume 38, Issue 2, Pages 277-+Publisher
SAGE PUBLICATIONS INC
DOI: 10.1111/j.1748-720X.2010.00488.x
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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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