title: Safety issues in cell-based intervention trials.
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.
authors: Phoebe R Berman Bioethics Institute, Johns Hopkins University, Baltimore, Maryland 21205, USA. rfaden@jhsph.edu
authors: Liza
authors: L
authors: Dawson
authors: Alison S
authors: AS
authors: Bateman-House
authors: Dawn
authors: D
authors: Mueller Agnew
authors: Hilary
authors: H
authors: Bok
authors: Dan W
authors: DW
authors: Brock
authors: Aravinda
authors: A
authors: Chakravarti
authors: Mark
authors: M
authors: Greene
authors: Patricia A
authors: PA
authors: King
authors: Stephen J
authors: SJ
authors: O'Brien
authors: David H
authors: DH
authors: Sachs
authors: Kathryn E
authors: KE
authors: Schill
authors: Andrew
authors: A
authors: Siegel
authors: Davor
authors: D
authors: Solter
authors: Sonia M
authors: SM
authors: Suter
authors: Catherine M
authors: CM
authors: Verfaillie
authors: LeRoy B
authors: LB
authors: Walters
authors: John D
authors: JD
authors: Gearhart
authors: Ruth R
authors: RR
authors: Faden
mesh_terms: D000818:Animals; D035843:Biomedical Research / Q000941:ethics*; D002460:Cell Line; D002986:Clinical Trials as Topic; D004353:Drug Evaluation, Preclinical; D020022:Genetic Predisposition to Disease; D006801:Humans; D017053:Infection Control; D011786:Quality Control; D013234:Stem Cells