Sources of Variability in Clinical Translation of Regenerative Engineering Products: Insights from the National Academies Forum on Regenerative Medicine

This perspective discusses insights from the National Academies Forum on Regenerative Medicine, which focused on identifying the many sources of variability encountered during regenerative engineering product development. We summarize several considerations about therapeutic development and clinical translation processes, which can be used to manage final product consistency. Lay Summary The variability in regenerative engineering products face challenges, especially for achieving product consistency and efficacy. This article discusses key sources of variability identified in the National Academies Forum on Regenerative Medicine.