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Allowing Innovative Stem Cell-Based Therapies Outside of Clinical Trials: Ethical and Policy Challenges.
- Source :
- Journal of Law, Medicine & Ethics; Summer2010, Vol. 38 Issue 2, p277-285, 9p
- Publication Year :
- 2010
-
Abstract
- 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. [ABSTRACT FROM AUTHOR]
- Subjects :
- STEM cells
CLINICAL trials
THERAPEUTICS
MEDICAL innovations
PATIENTS
Subjects
Details
- Language :
- English
- ISSN :
- 10731105
- Volume :
- 38
- Issue :
- 2
- Database :
- Complementary Index
- Journal :
- Journal of Law, Medicine & Ethics
- Publication Type :
- Academic Journal
- Accession number :
- 51545196
- Full Text :
- https://doi.org/10.1111/j.1748-720X.2010.00488.x