title: Assessing the safety of stem cell therapeutics.
abstract: 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.
authors.affiliation: MRC Centre for Drug Safety Science, Division of Molecular & Clinical Pharmacology, The Institute of Translational Medicine, The University of Liverpool, Liverpool L69 3GE, UK. C.E.P.Goldring@liverpool.ac.uk
authors.forename: Chris E P
authors.initials: CE
authors.lastname: Goldring
authors.forename: Paul A
authors.initials: PA
authors.lastname: Duffy
authors.forename: Nissim
authors.initials: N
authors.lastname: Benvenisty
authors.forename: Peter W
authors.initials: PW
authors.lastname: Andrews
authors.forename: Uri
authors.initials: U
authors.lastname: Ben-David
authors.forename: Rowena
authors.initials: R
authors.lastname: Eakins
authors.forename: Neil
authors.initials: N
authors.lastname: French
authors.forename: Neil A
authors.initials: NA
authors.lastname: Hanley
authors.forename: Lorna
authors.initials: L
authors.lastname: Kelly
authors.forename: Neil R
authors.initials: NR
authors.lastname: Kitteringham
authors.forename: Jens
authors.initials: J
authors.lastname: Kurth
authors.forename: Deborah
authors.initials: D
authors.lastname: Ladenheim
authors.forename: Hugh
authors.initials: H
authors.lastname: Laverty
authors.forename: James
authors.initials: J
authors.lastname: McBlane
authors.forename: Gopalan
authors.initials: G
authors.lastname: Narayanan
authors.forename: Sara
authors.initials: S
authors.lastname: Patel
authors.forename: Jens
authors.initials: J
authors.lastname: Reinhardt
authors.forename: Annamaria
authors.initials: A
authors.lastname: Rossi
authors.forename: Michaela
authors.initials: M
authors.lastname: Sharpe
authors.forename: B Kevin
authors.initials: BK
authors.lastname: Park
mesh_terms: D006801:Humans; D018570:Risk Assessment; D033581:Stem Cell Transplantation / Q000009:adverse effects* / Q000379:methods; D013234:Stem Cells