Tissue engineered constructs: perspectives on clinical translation.

In this article, a "bedside to bench and back" approach for developing tissue engineered medical products (TEMPs) for clinical applications is reviewed. The driving force behind this approach is unmet clinical needs. Preclinical research, both in vitro and in vivo using small and large animal models, will help find solutions to key research questions.

A program to provide regulatory support for investigator-initiated clinical research.

Investigator-initiated clinical trials represent a small but extremely important portion of medical research. In the process of translating basic science discoveries to novel therapies, new drugs or devices may be developed and tested. In light of increased compliance scrutiny, the need to streamline research projects, and the growing complexity of the U.