A global network of iPSC banks would create a strong future basis for new cellular therapies, providing GMP quality clinically complaint cell lines to facilitate research studies through to clinical trials. Setting up these banks requires clear and transparent re-consent of donors along with a strong QA and QC framework. We aim to provide a clear ethical pathway towards the creation of such a resource, along with a dynamic follow up and re-consent process of donors from the public BMDI Cord Blood Bank.
Review of the literature and a round-table workshop with Ethics and Legal experts have identified the key issues to be resolved in order to obtain consent to make iPSC lines from CB donors. Regulatory challenges that would affect global acceptance of any cell lines, along with the Quality framework and the standards required to operate as part of a global network, are being met by working in collaboration with bodies such as the Global Alliance for iPSC Therapies (GAiT) and participating in an iPSC Quality Assessment Round. CB donor letters and information sheets have been developed and Ethics approvals by an Institutional HREC, and government approval obtained. New issues of whole genome sequencing and the relevant donor safeguards and protections have been considered with input from clinical genetics services, including the rights and information flow to donors about what happens to the cells after banking and commercialization aspects. Freedom to operate and GMP manufacture and oversight is currently under investigation. This work is continuing and the ongoing success of many of these processes has confirmed feasibility and utility of using banked CB to produce clinical–grade iPSC lines for potential cellular therapies. Providing a standardized and characterized resource could lead to eventual new cell therapies that will be available to Australian and international communities.