ABSTRACT
Tissue-engineered devices are biologic-biomaterial combinations in which some component of tissue has been combined with a biomaterial to create a device for the restoration or modification of tissue or organ function. Four significant goals must be achieved if these devices are to function adequately and appropriately in the host environment. These four goals are (1) restoration of the target tissue with its appropriate function and cellular phenotypic expression; (2) inhibition of the macrophage and foreign body giant cell foreign body response that may degrade or adversely modify device function; (3) inhibition of scar and fibrous capsule formation that may be deleterious to the function of the device; and (4) inhibition of immune responses that may inhibit the proposed function of the device and ultimately lead to the destruction of the tissue component of the tissue-engineered device. The range of types of tissue-engineered devices is large, yet each device is considered to be unique in its combination of tissue component and biomaterial, thus requiring a unique set of tests to ensure that the four goals are achieved for the lifetime of the device in its in vivo environment.
