Balancing Safety and Innovation for Cell-Based Regenerative Medicine

Abstract

Regenerative medicine is a field that involves replacing, engineering, or regenerating human cells, tissues, or organs to establish, restore, or enhance normal function.1 It is an area with great promise that goes directly to the role of the Food and Drug Administration (FDA) in helping to facilitate the availability of safe and effective treatments. The broad scope of regenerative medicine products includes cell therapies, therapeutic tissue-engineering products, human cell and tissue products, and certain combination products involving cells and devices, such as scaffolds upon which cells can grow. Recently, there has been much interest specifically in the potential of adult stem cells to address a wide variety of conditions.