ABSTRACT

Three decades ago, tissue engineering and regenerative medicine (TERM) emerged as promising interdisciplinary fields with vast potential to revolutionize medical practices (Oerlemans et al. 2014). New approaches, such as construction of biological tissue substitutes for diagnostic and research applications, as well as replacement tissues or regenerative therapies for injured tissues, were touted as the next major breakthroughs. However in practice, translation to commercially robust clinical products has been a slow and difficult process (Berthiaume et al. 2011). In many cases long-term success rates have not been optimal, and costs associated with the regulatory process to bring these technologies to accepted clinical practice that can be reimbursed through health insurance plans have been staggering. This is not to say that progress has not been made. There are examples of successful clinical translation in skin (Han et al. 2014; Maver et al. 2015), cartilage (Fulco et al. 2014; Adachi et al. 2014), and bladder (Atala et al. 2006) repair or replacement, and while limited in patient number, recent studies have successfully implanted vaginal and urethral tissues in humans (Raya-

Wake Forest Institute for Regenerative Medicine, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157; Department of Cancer Biology, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157; Virginia Tech-Wake Forest School of Biomedical Engineering and Sciences, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157; Comprehensive Cancer Center of Wake Forest Baptist Medical Center, Medical Center Boulevard, Winston-Salem, NC 27157.