Abstract
Translation of recent advances in stem cell research into clinical trials for restorative therapies for human disease is accelerating dramatically, with a strong focus upon neurodegenerative disorders such as Parkinson's disease (PD), Huntington's disease (HD), and amyotrophic lateral sclerosis (ALS). It is likely that first-in-human intracerebral transplantation of cells derived from human embryonic stem cells (hESC) and inducible pluripotent cells (iPS) will occur within the next few years (Tabar and Studer, 2014) and intraspinal transplantation of hESC-derived cells has been recently reported in ALS. As clinical trials are planned and implemented, it will be critical to attend to the ethical framework necessary for responsible translation of these scientifically compelling, but risky, interventions in humans. In particular, these clinical trials will present a variety of challenges to the informed consent process (de Melo-Martin et al., 2015). We therefore review barriers to obtaining a truly informed consent in early phase stem cell clinical trials in neurodegenerative conditions, and we describe procedures and interventions that have been investigated to potentially address and overcome these barriers.
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