Providing an overview of those legal and regulatory elements that can significantly impact the clinical introduction of cell- and tissue-based products, this timely volume is an important reference at both the federal and state level. It discusses guidelines for the numerous current clinical trials for complex tissue constructs and cell therapies and considers the development of strategies for building patent portfolios for the increasing number of companies commercializing skin substitutes, expanded cell populations for cartilage repair, and extracellular materials intended to enable remodeling or repair at the implementation site.