Tissue engineering: current state of clinical application.

Despite several, mostly isolated successes, few controlled, prospective trials have yet validated clinical tissue engineering applications. Although this may, at least in part, be explained by the very young age of this field, tissue engineering involves the need for an elaborate and expensive infrastructure, not to mention qualified personnel. This translates into an inherent difficulty in establishing multicenter trials. Moreover, companies mostly devoted to tissue engineering have yet to prove themselves economically viable. On the other hand, although very few engineered tissues have been approved by the US Food and Drug Administration (FDA), more than 70 companies have recently been developing new products. Many challenges are yet to be overcome before "off-the-shelf" tissues can be offered commercially. Nevertheless, given the scientific promise, potential social impact, and young age of the field, many believe that it should be only a matter of time until tissue engineering reaches the mainstream of surgical practice.