抄録
Regenerative medicine, which involves advanced techniques using ex vivo processed tissue-engineering products (e.g., viable cells, tissues), is one of the newest and most promising methods for treating various intractable diseases and damaged organs. For clinical use, tissue-engineered products require sterilization, so they are usually prepared manually, using aseptic processing procedures in a biological clean room (BCR) to prevent contamination with microbiological and/or hazardous materials. However, these procedures carry the unavoidable risk of contamination from the people performing them. To reduce this risk, personnel are required to wear sterilized gowns and follow written standard operating procedures (SOPs) for every process. These measures make procedures performed in the BCR laborious and expensive. In this study, to develop a system for producing tissue engineering products that is safer, less laborious, and less expensive than those used in the BCR, we examined the applicability of an isolator system for human cell cultures and developed a new system, the Advanced Isolator System for Tissue Engineering (AIST). The AIST is a compact, closed isolator system intended for aseptic human cell cultures. It has a built-in CO2 incubator and the equipment needed for cell culture (e.g., microscope, centrifuge) is set up inside it. It is decontaminated in its entirety by vaporized hydrogen peroxide (VHP), and it can be maintained in a cleaner condition with less effort than equipment in a BCR. We have been able to culture various human cells in the microbiologically closed AIST using a half-suit unit as the operator interface, so the potential risk of contamination from personnel is as low as possible. Cell processing in the AIST will maintain the quality of human cells for clinical use at a higher level than can be attained in a BCR, and we expect it to contribute greatly to the early realization of regenerative medicine using ex vivo processed human cells.
