Tissue engineering: functional assessment and clinical outcome.

The issues that should be considered as part of the design and evaluation of tissue engineering constructs with respect to their targeted clinical application are reviewed. This paper provides a general framework for the process of bringing tissue-engineering constructs from the laboratory bench to the patient's bedside, rather than presenting a detailed review of the engineering or biologic principles or mechanisms that are necessary for successful tissue engineering. Many of the principles are animated by using examples from current studies being developed in my laboratory or those of my collaborators. In all likelihood, multiple solutions or approaches will be found that lead to successful tissue-engineering constructs. The focus here is on the identification of critical parameters to be considered rather than specific design solutions. The review is therefore organized to reflect feasible sequences of activities formulated to take tissue engineering from concept to clinical reality.