Regenerative MedicineEthical Considerations in Stem Cell Research on Neurologic and Orthopedic Conditions

The range and gravity of ethical considerations in stem cell research are remarkable and, quite possibly, unprecedented. From the point of securing stem cells for implantation, through the translational and first-in-humans process, and then proceeding through clinical trials culminating in product or service line launch, the entire research trajectory is replete with risk, uncertainty, and problems overweighing foreseeable harms against hoped-for benefits. This article offers an overview of some of the most salient ethical challenges of stem cell research, including ones involving moral status, the intersection of research risks and informed consent processes, methodologic considerations in early phase 1 trials, the temptation to exaggerate the benefits of research discoveries, managing conflicts of interest, and the ethical obligation to conduct various monitoring practices throughout a trial, which could last years. The article will conclude with a glimpse into the future of these technologies wherein the need for ethical scrutiny will likely not diminish.