title: Uncertain translation, uncertain benefit and uncertain risk: ethical challenges facing first-in-human trials of induced pluripotent stem (ips) cells.
abstract: The discovery of induced pluripotent stem (iPS) cells in 2006 was heralded as a major breakthrough in stem cell research. Since then, progress in iPS cell technology has paved the way towards clinical application, particularly cell replacement therapy, which has refueled debate on the ethics of stem cell research. However, much of the discourse has focused on questions of moral status and potentiality, overlooking the ethical issues which are introduced by the clinical testing of iPS cell replacement therapy. First-in-human trials, in particular, raise a number of ethical concerns including informed consent, subject recruitment and harm minimisation as well as the inherent uncertainty and risks which are involved in testing medical procedures on humans for the first time. These issues, while a feature of any human research, become more complex in the case of iPS cell therapy, given the seriousness of the potential risks, the unreliability of available animal models, the vulnerability of the target patient group, and the high stakes of such an intensely public area of science. Our paper will present a detailed case study of iPS cell replacement therapy for Parkinson's disease to highlight these broader ethical and epistemological concerns. If we accept that iPS cell technology is fraught with challenges which go far beyond merely refuting the potentiality of the stem cell line, we conclude that iPS cell research should not replace, but proceed alongside embryonic and adult somatic stem cell research to promote cross-fertilisation of knowledge and better clinical outcomes.
authors: University of Sydney-Centre for Values, Ethics and the Law in Medicine, University of Sydney, Camperdown Sydney New South Wales, Australia. rfun6468@uni.sydney.edu.au
authors: Ronald K F
authors: RK
authors: Fung
authors: Ian H
authors: IH
authors: Kerridge
mesh_terms: D006805:Human Experimentation / Q000941:ethics*; D006801:Humans; D057026:Induced Pluripotent Stem Cells / Q000637:transplantation*; D007258:Informed Consent / Q000941:ethics; D010300:Parkinson Disease / Q000628:therapy*; D018579:Patient Selection / Q000941:ethics; D018570:Risk Assessment; D012308:Risk Management; D033581:Stem Cell Transplantation / Q000941:ethics*; D057170:Translational Research, Biomedical / Q000941:ethics*; D035501:Uncertainty