Biology Faculty Articles

Title

Safety Issues in Cell-Based Intervention Trials

Document Type

Article

Publication Date

11-2003

Publication Title

Fertility and Sterility

Keywords

Clinical trials, Ethics, Phase I, Preclinical testing, Science policy, Stem cells, Xenotransplantation

ISSN

0015-0282

Volume

80

Issue/No.

5

First Page

1077

Last Page

1085

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.

Comments

©2003 American Society for Reproductive Medicine

Additional Comments

Erratum: Fertility and Sterility 81(1):226, 2004 (DOI: 10.1016/j.fertnstert.2003.11.003)

ORCID ID

0000-0001-7353-8301

ResearcherID

N-1726-2015

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