id author title date pages extension mime words sentences flesch summary cache txt cord-006127-rl7rur2j Brown, Nik Regulating Hybrids: ‘Making a Mess’ and ‘Cleaning Up’ in Tissue Engineering and Transpecies Transplantation 2006-02-08 .txt text/plain 8926 417 40 Developing a conceptual vocabulary for understanding the relationship between material and institutional hybrids, the paper compares human tissue engineering (TE) and xenotransplantation (XT), areas of innovation which regulators have sought to govern separately and in isolation from one another. Human and animal matters, cell cultures and tissue products have much greater corporeal connection than has been institutionally recognized, and are therefore a source of acute instability in the regulation of implants and transplants. While the troubled nature of transplantation has been relatively well documented (eg Swazey, 1978, 1992) , less well understood are new forms of innovation that cut across machines, humans and animals raising regulatory concerns about material and cultural risk (Brown and Michael, 2004; Faulkner et al., 2004; Kent et al., 2005) . The previous definition used by the FDA and the British regulatory body for XT (the United Kingdom Xenotransplantation Interim Regulatory Authority, 2003) did not account for production methods whereby human and animal tissues may be subject to 'ex-vivo contact' as is the case with Epicelt. ./cache/cord-006127-rl7rur2j.txt ./txt/cord-006127-rl7rur2j.txt