ESTABLISHING THE ETHICAL AND REGULATORY FRAME WORK FOR A CLINICALLY COMPLIANT IPSC CELL LINE BANK; FROM QA TO DONOR RECONSENT.

Abstract

Background & Aim A global network of iPSC banks would create a strong future basis for new cellular therapies, providing GMP quality clinically complaint cell lines to produce differentiated cells to facilitate research studies through to clinical trials. Cryopreserved Cord Blood (CB) is an excellent starting material for iPSC production, however setting up these banks requires clear and transparent reconsent 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 reconsent process of donors from the public BMDI Cord Blood Bank. Methods, Results & Conclusion Review of the literatu..