Concise review: Workshop review: Understanding and assessing the risks of stem cell-based therapies

James A. Heslop, Thomas G. Hammond, Ilaria Santeramo, Agnés Tort Piella, Isabel Hopp, Jing Zhou, Roua Baty, Enrique I. Graziano, Bernabè Proto Marco, Alexis Caron, Patrik Sköld, Peter W. Andrews, Melissa A. Baxter, David C. Hay, Junnat Hamdam, Michaela E. Sharpe, Sara Patel, David R. Jones, Jens Reinhardt, Erik H.J. DanenUri Ben-David, Glyn Stacey, Petter Björquist, Jacqueline Piner, John Mills, Cliff Rowe, Giovanni Pellegrini, Swaminathan Sethu, Daniel J. Antoine, Michael J. Cross, Patricia Murray, Dominic P. Williams, Neil R. Kitteringham, Chris E.P. Goldring, Chris E.P. Goldring, B. Kevin Park

Research output: Contribution to journalReview articlepeer-review


The field of stem cell therapeutics is moving ever closer to widespread application in the clinic. However, despite the undoubted potential held by these therapies, the balance between risk and benefit remains difficult to predict. As in any new field, a lack of previous application in man and gaps in the underlying science mean that regulators and investigators continue to look for a balance between minimizing potential risk and ensuring therapies are not needlessly kept from patients. Here, we attempt to identify the important safety issues, assessing the current advances in scientific knowledge and how they may translate to clinical therapeutic strategies in the identification and management of these risks. We also investigate the tools and techniques currently available to researchers during preclinical and clinical development of stem cell products, their utility and limitations, and how these tools may be strategically used in the development of these therapies. We conclude that ensuring safety through cutting-edge science and robust assays, coupled with regular and open discussions between regulators and academic/industrial investigators, is likely to prove the most fruitful route to ensuring the safest possible development of new products.

Original languageEnglish
Pages (from-to)389-400
Number of pages12
JournalStem cells translational medicine
Issue number4
StatePublished - 2015
Externally publishedYes


FundersFunder number
Medical Research CouncilMR/K026739/1, G0700654, MR/L012537/1, MR/L006758/1, MR/L01324X/1


    • Adult stem cells
    • Autologous stem cell transplantation
    • Cellular therapy
    • In vivo tracking
    • Pluripotent stem cells
    • Stem cell
    • Stem cell expansion
    • Stem cell transplantation


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