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Human pluripotent stem cells (hPSCs) have the potential to transform medicine. However, hurdles remain to ensure safety for such cellular products. Science-based understanding of the requirements for source materials is required as are appropriate materials. Leaders in hPSC biology, clinical translation, bio-manufacturing and regulatory issues were brought together to define requirements for source materials for the production of hPSCderived therapies and to identify other key issues for the safety of cell therapy products. Whilst the focus of this meeting was on hPSC-derived cell therapies, many if the issues are generic to all cell-based medicines. The intent of this report is to summarise the key issues discussed and record the consensus reached on each of these by the expert delegates.

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