Concise Review: Workshop Review: Understanding and Assessing the Risks of Stem Cell-Based Therapies
Year: 2015
Type: review
Abstract: 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.
Authors: James A. Heslop, Thomas G. Hammond, Ilaria Santeramo, Agnès Tort Piella, Isabel Hopp, Jing Zhou, Roua Baty, Enrique I. Graziano, Bernabé 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. Danen, Uri 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, B. Kevin Park
Institutions: University of Liverpool, Medical Research Council, University of Basel, Almirall (Spain), Sanofi (France), Uppsala University, University of Sheffield, University of Manchester, MRC Centre for Regenerative Medicine, University of Edinburgh, Heinrich Heine University Düsseldorf, ReNeuron (United Kingdom), Medicines and Healthcare products Regulatory Agency, Paul Ehrlich Institut, Leiden University, Hebrew University of Jerusalem, National Institute for Biological Standards and Control, GlaxoSmithKline (United Kingdom), AstraZeneca (United Kingdom), CN Bio Innovations (United Kingdom), University of Zurich, Vellore Institute of Technology University, Innovative Medicines Initiative
Language: English
Subfield: Physiology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,963
OpenAlex ID: W1998782859