To date, more than 100 clinical trials with human pluripotent stem cell (hPSC)-derived products have been initiated worldwide and an increasing number of potential hPSC-derived clinical products have entered early developmental pipelines. For off-the-shelf (allogeneic) products, the identification and selection of the right hPSC line early on during this process is of utmost importance as failure to do so may delay or completely stall product development. While developers acknowledge the importance of this issue, a comprehensive, accessible listing of globally available hPSC lines to inform cell line selection for clinical use has been elusive until now.
To address this knowledge gap, Tenneille Ludwig, WiCell Research Institute, and Melissa Carpenter, Carpenter Consulting Corporation, have screened the scientific literature, websites, and gathered information from hPSC manufacturers to identify 166 hPSC lines for use in clinical applications which are currently available from 18 global distributors. Critical details about those cell lines including informed consent procedures, donor sex, blood and HLA type, quality standards applied, and modalities for licencing and distribution were compiled into a paper published today in the journal Stem Cell Reports. This unique resource will guide researchers and developers in selecting the optimal cell line for their specific needs with the goal to drive hPSC-derived products towards the clinic.
Source:
Journal reference:
Carpenter, M. K. & Ludwig, T. E. (2025). Pluripotent stem cell lines available for use in clinical applications: A comprehensive overview. Stem Cell Reports. doi: 10.1016/j.stemcr.2025.102741. https://www.cell.com/stem-cell-reports/fulltext/S2213-6711(25)00345-5