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)
|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|
|Keywords||No keywords specified (fix it)|
|Through your library||Configure|
Similar books and articles
Ruth R. Faden, Liza Dawson, Alison S. Bateman-House, Dawn Mueller Agnew, Hilary Bok, Dan W. Brock, Aravinda Chakravarti, Xiao-Jiang Gao, Mark Greene, John A. Hansen, Patricia A. King, Stephen J. O.’Brien & David H. Sachs (2003). Public Stem Cell Banks: Considerations of Justice in Stem Cell Research and Therapy. Hastings Center Report 33 (6):13-27.
Cynthia B. Cohen Peter J. Cohen (2010). International Stem Cell Tourism and the Need for Effective Regulation: Part I: Stem Cell Tourism in Russia and India: Clinical Research, Innovative Treatment, or Unproven Hype? Kennedy Institute of Ethics Journal 20 (1):pp. 27-49.
Insoo Hyun (2008). 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. [REVIEW] American Journal of Bioethics 8 (6):57 – 59.
Cynthia B. Cohen Peter J. Cohen (2010). International Stem Cell Tourism and the Need for Effective Regulation: Part II: Developing Sound Oversight Measures and Effective Patient Support. Kennedy Institute of Ethics Journal 20 (3):207-230.
Aaron D. Levine & Leslie E. Wolf (2012). The Roles and Responsibilities of Physicians in Patients' Decisions About Unproven Stem Cell Therapies. Journal of Law, Medicine and Ethics 40 (1):122-134.
Ronald K. F. Fung & Ian H. Kerridge (2013). Uncertain Translation, Uncertain Benefit and Uncertain Risk: Ethical Challenges Facing First-in-Human Trials of Induced Pluripotent Stem (Ips) Cells. Bioethics 27 (2):89-96.
Nikolaus Knoepffler (2004). Stem Cell Research: An Ethical Evaluation of Policy Options. Kennedy Institute of Ethics Journal 14 (1):55-74.
Bernard Lo & Lindsay Parham (2010). Resolving Ethical Issues in Stem Cell Clinical Trials: The Example of Parkinson Disease. Journal of Law, Medicine and Ethics 38 (2):257-266.
Liza Dawson, Alison S. Bateman-House, Dawn Mueller Agnew, Hilary Bok, Dan W. Brock, Aravinda Chakravarti, Mark Greene, Patricia King, Stephen J. O'Brien, David H. Sachs, Kathryn E. Schill, Andrew Siegel & Davor Solter (2003). Safety Issues In Cell-Based Intervention Trials. Fertility and Sterility 80 (5):1077-1085.
David Magnus (2010). Translating Stem Cell Research: Challenges at the Research Frontier. Journal of Law, Medicine and Ethics 38 (2):267-276.
Added to index2010-08-11
Total downloads5 ( #160,518 of 549,769 )
Recent downloads (6 months)0
How can I increase my downloads?