Perspectives from the 2025 ISCBI/ISCI joint workshop on genetic stability, clonal monitoring, ethical data governance, and global inclusion in stem cell banking

Two international stem cell consortia, the International Stem Cell Initiative (ISCI) and the International Stem Cell Biobanking Initiative (ISCBI, www.iscbi.org) held a workshop on June 15th 2025 in Hong Kong on genetic variants in human pluripotent stem cell (hPSC) lines and accurate and standardized documentation of donor/hPSC genetic information including ethnicity. The occurrence and detection of genetic variants is a key issue for assuring reproducible stem cell research data and the safety of stem cell derived medicinal products. Presentations by leading experts addressed the nature of hPSC genetic variants, their detection and accurate recording of genetic data and ethnicity. The audience of stem cell researchers, cell banking directors and experts in ethic, policy and stem cell databases, from 13 countries across the globe, discussed progression of the ISCI consortium’s efforts in providing further data and thought leadership on the management of genetic variants, and the challenges for standardizing biobanking approaches for hPSC genetic data including ethnicity. This paper records the key elements of this discussion and the conclusions and consensus reached and ongoing work to provide guidance for hPSC biobanks.