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Science-based assessment of source materials for cell-based medicines: report of a stakeholders workshop.
Stacey, Glyn; Andrews, Peter; Asante, Curtis; Barbaric, Ivana; Barry, Jaqueline; Bisset, Louise; Braybrook, Julian; Buckle, Robin; Chandra, Amit; Coffey, Peter; Crouch, Sharon; Driver, Philip; Evans, Amanda; Gardner, John; Ginty, Patrick; Goldring, Christopher; Hay, David C; Healy, Lyn; Hows, Anna; Hutchinson, Claire; Jesson, Helen; Kalber, Tammy; Kimber, Sue; Leathers, Roland; Moyle, Sarah; Murray, Trish; Neale, Michael; Pan, David; Park, B Kevin; Rebolledo, Raul Elgueta; Rees, Ian; Rivolta, Marcelo N; Ritchie, Allan; Roos, Eric J; Saeb-Parsy, Kourosh; Schröder, Bernd; Sebastian, Sujith; Thomas, Angela; Thomas, Robert J; Turner, Marc; Vallier, Ludovic; Vitillo, Loriana; Webster, Andrew; Williams, David.
Afiliação
  • Stacey G; International Stem Cell Banking Initiative, 2 High Street, Barley, Hertfordshire, SG8 8HZ, UK.
  • Andrews P; Department of Biomedical Sciences, Centre for Stem Cell Biology, University of Sheffield, Sheffield, South Yourkshire, S10 2TN, UK.
  • Asante C; Centre for Stem Cells & Regenerative Medicine, King's College London, Guy's Campus, London, SE1 9RT, UK.
  • Barbaric I; Department of Biomedical Sciences, Centre for Stem Cell Biology, University of Sheffield, Sheffield, South Yourkshire, S10 2TN, UK.
  • Barry J; Cell & Gene Therapy Catapult, London, SE1 9RT, UK.
  • Bisset L; Medicines & Healthcare Products Regulatory Agency, London, E14 4PU, UK.
  • Braybrook J; LGC Ltd, National Measurement Laboratory, Teddington, TW11 0LY, UK.
  • Buckle R; Medical Research Council, London, WC2B 4AN, UK.
  • Chandra A; Yposkesi, 91100 Corbiel-Essonnes, France.
  • Coffey P; University of California, Neuroscience Research Institue, Santa Barbara, CA, 93106, USA.
  • Crouch S; Institute of Opthalmology, University College London, London, WC1E 6BT, UK.
  • Driver P; Financial & Business Services, University of Nottingham, Nottingham, NG7 2RD, UK.
  • Evans A; Royal Society of Chemistry, London, W1J 0BA, UK.
  • Gardner J; University of Cambridge/NHS Blood & Transplant, Long Road, CB2 0PT, Cambridge, UK.
  • Ginty P; School of Social Sciences, Monash University, Victoria, Australia.
  • Goldring C; Regulatory Affairs, Cell and Gene Therapy Catapult, London, SE1 9RT, UK.
  • Hay DC; Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, L69 3GE, UK.
  • Healy L; University of Edinburgh, MRC Centre for Regenerative Medicine, Edinburgh, EH16 4UU, UK.
  • Hows A; Francis Crick Institute, London, NW1 1AT, UK.
  • Hutchinson C; Miltenyi Biotec, Bisley, GU24 9DR, UK.
  • Jesson H; Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, L69 3GE, UK.
  • Kalber T; Centre for Biological Engineering, Loughborough University, Loughborough, LE11 3TU, UK.
  • Kimber S; Centre for Advanced Biomedical Imaging, University College London, WC1E 6BT, UK.
  • Leathers R; Division of Cell Matrix Biology and Regenerative Medicine; Director EPSRC/MRC in Regenerative Medicine, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester, M13 9PT, UK.
  • Moyle S; Thermo Fisher Scientific, CH-4123 Allschwil, CH, USA.
  • Murray T; Clinical Biomanufacturing Facility, Oxford University, Oxford, OX3 7JT, UK.
  • Neale M; Department of Physiology, University of Liverpool, Liverpool, L69 3GE, UK.
  • Pan D; Institute of Opthalmology, University College London, London, WC1E 6BT, UK.
  • Park BK; Medical Research Council, London, WC2B 4AN, UK.
  • Rebolledo RE; Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, L69 3GE, UK.
  • Rees I; Allan Ritchie Medical Device Consulting, Harrogate, HG1 1BX, UK.
  • Rivolta MN; Medicines & Healthcare Products Regulatory Agency, London, E14 4PU, UK.
  • Ritchie A; Department of Biomedical Sciences, Centre for Stem Cell Biology, University of Sheffield, Sheffield, South Yourkshire, S10 2TN, UK.
  • Roos EJ; Allan Ritchie Medical Device Consulting, Harrogate, HG1 1BX, UK.
  • Saeb-Parsy K; Thermofisher, Boston, MA, USA.
  • Schröder B; Department of Surgery, University fo Cambridge, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.
  • Sebastian S; Miltenyi Biotec GmbH, 51429 Bergisch Gladbach, Nordrhein-Westfalen, Germany.
  • Thomas A; School of Bioscience, University of East Anglia, Norwich Research Park, Norwich, NR4 7TJ, UK.
  • Thomas RJ; College of Medicine and Veterinary Medicine, University of Edinburgh, Edinburgh, EH16 4TJ, UK.
  • Turner M; Centre for Biological Engineering, Loughborough University, Loughborough, LE11 3TU, UK.
  • Vallier L; Scottish National Blood Transfusion Service, Edinburgh, EH14 4BE, UK.
  • Vitillo L; Wellcome-Medical Research Council Cambridge Stem Cell Institute and Department of Surgery, University of Cambridge, Cambridge UK.
  • Webster A; Institute of Opthalmology, University College London, London, WC1E 6BT, UK.
  • Williams D; SATSU, Department of Sociology, University of York, York, YO10 5DD, UK.
Regen Med ; 13(8): 935-944, 2018 12.
Article em En | MEDLINE | ID: mdl-30488776
Human pluripotent stem cells (hPSCs) have the potential to transform medicine. However, hurdles remain to ensure safety for such cellular products. Science-based understanding of the requirements for source materials is required as are appropriate materials. Leaders in hPSC biology, clinical translation, biomanufacturing and regulatory issues were brought together to define requirements for source materials for the production of hPSC-derived therapies and to identify other key issues for the safety of cell therapy products. While the focus of this meeting was on hPSC-derived cell therapies, many of the issues are generic to all cell-based medicines. The intent of this report is to summarize the key issues discussed and record the consensus reached on each of these by the expert delegates.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Células-Tronco Pluripotentes / Medicina Regenerativa / Segurança do Paciente / Terapia Baseada em Transplante de Células e Tecidos Idioma: En Ano de publicação: 2018 Tipo de documento: Article
Texto completo
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XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Células-Tronco Pluripotentes / Medicina Regenerativa / Segurança do Paciente / Terapia Baseada em Transplante de Células e Tecidos Idioma: En Ano de publicação: 2018 Tipo de documento: Article