Safety Issues In Cell-Based Intervention Trials

Fertility and Sterility 80 (5):1077-1085 (2003)
  Copy   BIBTEX

Abstract

We report on the deliberations of an interdisciplinary group of experts in science, law, and philosophy who convened to discuss novel ethical and policy challenges in stem cell research. In this report we discuss the ethical and policy implications of safety concerns in the transition from basic laboratory research to clinical applications of cell-based therapies derived from stem cells. Although many features of this transition from lab to clinic are common to other therapies, three aspects of stem cell biology pose unique challenges. First, tension regarding the use of human embryos may complicate the scientific development of safe and effective cell lines. Second, because human stem cells were not developed in the laboratory until 1998, few safety questions relating to human applications have been addressed in animal research. Third, preclinical and clinical testing of biologic agents, particularly those as inherently complex as mammalian cells, present formidable challenges, such as the need to develop suitable standardized assays and the difficulty of selecting appropriate patient populations for early phase trials. We recommend that scientists, policy makers, and the public discuss these issues responsibly, and further, that a national advisory committee to oversee human trials of cell therapies be established. **NB we did not reccommend a NAC, we think it might be appropriate**.

Links

PhilArchive



    Upload a copy of this work     Papers currently archived: 74,429

External links

Setup an account with your affiliations in order to access resources via your University's proxy server

Through your library

Similar books and articles

Stem Cell Research: An Ethical Evaluation of Policy Options.Nikolaus Knoepffler - 2004 - Kennedy Institute of Ethics Journal 14 (1):55-74.
Moral Complicity in Induced Pluripotent Stem Cell Research.Mark T. Brown - 2009 - Kennedy Institute of Ethics Journal 19 (1):pp. 1-22.
Ethical Issues in Human Embryonic Stem Cell Research.Philip J. Nickel - 2008 - In Kristen Renwick Monroe, Ronald B. Miller & Jerome Tobis (eds.), Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical & Political Issues. University of California Press.
Social Experiments in Stem Cell Biology.Melinda B. Fagan - 2011 - Perspectives on Science 19 (3):235-262.
Will Embryonic Stem Cells Change Health Policy?William M. Sage - 2010 - Journal of Law, Medicine and Ethics 38 (2):342-351.

Analytics

Added to PP
2011-10-24

Downloads
36 (#321,656)

6 months
1 (#416,470)

Historical graph of downloads
How can I increase my downloads?

Author's Profile

Mark Edward Greene
University of Delaware

References found in this work

No references found.

Add more references