TY - JOUR
T1 - Assessing the safety of stem cell therapeutics
AU - Goldring, Chris E.P.
AU - Duffy, Paul A.
AU - Benvenisty, Nissim
AU - Andrews, Peter W.
AU - Ben-David, Uri
AU - Eakins, Rowena
AU - French, Neil
AU - Hanley, Neil A.
AU - Kelly, Lorna
AU - Kitteringham, Neil R.
AU - Kurth, Jens
AU - Ladenheim, Deborah
AU - Laverty, Hugh
AU - McBlane, James
AU - Narayanan, Gopalan
AU - Patel, Sara
AU - Reinhardt, Jens
AU - Rossi, Annamaria
AU - Sharpe, Michaela
AU - Park, B. Kevin
N1 - Funding Information:
C.E.P.G., R.E., N.F., N.A.H., L.K., N.R.K., H.L., and B.K.P. would like to thank the Medical Research Council (MRC); Frank Bonner, Ernie Harpur, and Rebecca Lumsden at Stem Cells for Safer Medicines; and The Association of British Pharmaceutical Companies (ABPI). C.E.P.G and R.E. thank Gillian Wallace and acknowledge the support of Life Technologies. N.H. acknowledges the support of The Wellcome Trust and The National Institute for Health Research. Peter Andrews wishes to thank the MRC and Yorkshire Cancer Research (YCR). An Industry-Academic-Regulator workshop that was held in Liverpool, UK, on Nov. 24, 2010, formed the initiative for the development of this manuscript.
PY - 2011/6/3
Y1 - 2011/6/3
N2 - Unprecedented developments in stem cell research herald a new era of hope and expectation for novel therapies. However, they also present a major challenge for regulators since safety assessment criteria, designed for conventional agents, are largely inappropriate for cell-based therapies. This article aims to set out the safety issues pertaining to novel stem cell-derived treatments, to identify knowledge gaps that require further research, and to suggest a roadmap for developing safety assessment criteria. It is essential that regulators, pharmaceutical providers, and safety scientists work together to frame new safety guidelines, based on "acceptable risk," so that patients are adequately protected but the safety "bar" is not set so high that exciting new treatments are lost.
AB - Unprecedented developments in stem cell research herald a new era of hope and expectation for novel therapies. However, they also present a major challenge for regulators since safety assessment criteria, designed for conventional agents, are largely inappropriate for cell-based therapies. This article aims to set out the safety issues pertaining to novel stem cell-derived treatments, to identify knowledge gaps that require further research, and to suggest a roadmap for developing safety assessment criteria. It is essential that regulators, pharmaceutical providers, and safety scientists work together to frame new safety guidelines, based on "acceptable risk," so that patients are adequately protected but the safety "bar" is not set so high that exciting new treatments are lost.
UR - http://www.scopus.com/inward/record.url?scp=79957856719&partnerID=8YFLogxK
U2 - 10.1016/j.stem.2011.05.012
DO - 10.1016/j.stem.2011.05.012
M3 - ???researchoutput.researchoutputtypes.contributiontojournal.systematicreview???
AN - SCOPUS:79957856719
SN - 1934-5909
VL - 8
SP - 618
EP - 628
JO - Cell Stem Cell
JF - Cell Stem Cell
IS - 6
ER -