From lab bench to market: critical issues in tissue engineering.

Revolutionary advances in tissue engineering are redefining approaches to tissue repair and transplantation through the creation of replacement tissues that remain biointeractive after implantation, imparting physiologic functions as well as structure to the tissue or organ damaged by disease or trauma.(1,2) Over the last decade this field has moved from "science fiction" to "science fact" with the research-oriented acceptance of its potential to regulatory approvals allowing commercial products to be available for use in many countries. The maintenance of tissue integrity, functionality, and viability from cell seeding through product manufacture, shipping, and end-use has been accomplished through innovations in design and scale-up of both tissue growth and preservation processes. These unique systems have enabled the delivery of tissue-engineered products that are uniform inter- and intra-lot, readily available as off-the-shelf products, easy to use, and efficacious. Skin replacement products are the most advanced, with several tissue-engineered wound care materials on the market in the U.S. and in several international communities.(3-5) The potential impact of this field is far broader, offering novel solutions to the medical field for drug screening and development, genetic engineering, and total tissue and organ replacement.