Setting quality standards for stem cell banking, research and translation: the international stem cell banking initiative
Delivery of human stem cells for research, clinical translation, and commercialization ideally requires stem cell resources developed and maintained according to internationally recognized standards. For example, human embryonic stem (hES) cells and induced pluripotent stem (iPS) cells should conform to international ethical principles imparted by leading bodies such as the International Society of Stem Cell Research (ISSCR; www.isscr.org), International Stem Cell Forum (ISCF; www.stem-cell-forum.net), and U.S. National Academy of Sciences (USNAS; www.nasonline.org), and be quality-controlled based on principles of best-practice for manufacture, culture, characterization, storage, distribution, and translation. The International Stem Cell Banking Initiative (ISCBI) has taken the lead in defining such principles so as to standardize current and future practices that are essential to good scientific practice and clinical use through regulatory and public approval. This chapter considers the importance of standardizing stem cell banking and the central role of ISCBI as a major proponent of coordinated hES and iPS cell banking.