Biocompatibility Issues for The Tissue EngineeredProducts for Commercialization

Around ۱۹۹۲ as ۲۰ years ago, Advance Tissue Science Co(USA), now merged to Smith & Nephew Co., USA, had beensubmitted to approve to USA FDA for firs t cartilage TEMPsas autologous chondrocyte/polyglycolic acid (PGA) nonwovenscaffold. At that time, no one had doubted to approve cartilageTEMPs since PGA was already approved by FDA in humanclinical trial and chondrocyte was used autologous primary cell.At las t, this product has been s till retard up to approve FDA.Main reason might be in terms of safety. Implanted TEMPshave been reported to induce sequential events of immunologicreactions in response to injury caused by implantation proceduresand result in acute inflammation marked by a dense infiltrationof inflammation-mediating cells at the materials-tissueinterface. Prolonged irritations provoked by implanted biomaterialsadvance acute inflammation into chronic adverse tissueresponse characterized by the accumulation of dense fibrotictissue encapsulating the implants.In this lecture, we will discuss ۱. recent advances for thecommercialization trends for the tissue engineered products(TEMPS) including regenerative medicinal products, ۲. scaffoldsin terms of biocompatibility and safety issue, ۳. smartscaffold for the application of clinical trial including improvedbiocompatibility and the reduction of hos t response, and ۴. biocompatibilityissue for the natural and synthetic polymers.