Abstract
The lack of reliable therapies for regeneration or repair of the injured central nervous system, coupled with the promise of iPSC-derived neurons in basic and preclinical studies, has led to rapid expansion of research and development into this area (Boer, 2010; Meloni, Mallet, Faucon-Biguet, 2011). Alongside the promise of iPSC-derived treatments are uncertainties that remain with regard to safety, effectiveness, efficiency, and quality. The field of regenerative neurological therapeutics is entering into early phase clinical trials to assess and establish safety and efficacy of therapies that are not only palliative, but also potentially curative (see Wu et al., 2018). Scientific and regulatory communities must now face questions about the ethical, legal, and social implications (ELSI), as well as the potential social value and utility of these approaches. This article provides an introduction to these ELSI issues and a framework to assist in addressing the issues raised.