Quality control guidelines for clinical-grade human induced pluripotent stem cell lines

Stephen Sullivan, Glyn N. Stacey, Chihiro Akazawa, Naoki Aoyama, Ricardo Baptista, Patrick Bedford, Annelise Bennaceur Griscelli, Amit Chandra, Ngaire Elwood, Mathilde Girard, Shin Kawamata, Tadaaki Hanatani, Theodoros Latsis, Stephen Lin, Tenneille E. Ludwig, Tamara Malygina, Amanda Mack, Joanne C. Mountford, Scott Noggle, Lygia V. PereiraJack Price, Michael Sheldon, Alok Srivastava, Harald Stachelscheid, Shaji R. Velayudhan, Natalie J. Ward, Marc L. Turner, Jacqueline Barry, Jihwan Song

    Research output: Contribution to journalArticlepeer-review

    115 Scopus citations


    Use of clinical-grade human induced pluripotent stem cell (iPSC) lines as a starting material for the generation of cellular therapeutics requires demonstration of comparability of lines derived from different individuals and in different facilities. This requires agreement on the critical quality attributes of such lines and the assays that should be used. Working from established recommendations and guidance from the International Stem Cell Banking Initiative for human embryonic stem cell banking, and concentrating on those issues more relevant to iPSCs, a series of consensus workshops has made initial recommendations on the minimum dataset required to consider an iPSC line of clinical grade, which are outlined in this report. Continued evolution of this field will likely lead to revision of these guidelines on a regular basis.

    Original languageEnglish (US)
    Pages (from-to)859-866
    Number of pages8
    JournalRegenerative Medicine
    Issue number7
    StatePublished - Oct 2018

    All Science Journal Classification (ASJC) codes

    • Biomedical Engineering
    • Embryology


    • clinical-grade induced pluripotent stem cells
    • good manufacturing practice
    • minimum testing requirements
    • quality control
    • quality control attributes


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