Science-based assessment of source materials for cell-based medicines: report of a stakeholders workshop

Autor: Louise Bisset, David Pan, Julian Braybrook, Raul Elgueta Rebolledo, Marcelo N. Rivolta, Christopher E. Goldring, Sujith Sebastian, B. Kevin Park, Angela E Thomas, Eric J. Roos, John Gardner, Bernd Schröder, Roland Leathers, Jacqueline Barry, Andrew Webster, Ludovic Vallier, Michael H Neale, Glyn Stacey, Susan J. Kimber, Peter W. Andrews, Philip Driver, Sharon Patricia Mary Crouch, Loriana Vitillo, Robin Buckle, Helen Jesson, Lyn Healy, Peter J. Coffey, David J. Williams, Anna Hows, Amit Chandra, Claire Hutchinson, Robert Thomas, Sarah Moyle, Allan Ritchie, Ivana Barbaric, Marc Turner, Trish Murray, Tammy L. Kalber, David C. Hay, Amanda L. Evans, Curtis O. Asante, Kourosh Saeb-Parsy, Patrick J. Ginty, Ian Rees
Rok vydání: 2018
Předmět:
Zdroj: Stacey, G, Andrews, P, Asante, C, Barbaric, I, Barry, J, Bisset, L, Braybrook, J, Buckle, R, Chandra, A, Coffey, P, Crouch, S, Driver, P, Evans, A, Gardner, J, Ginty, P, Goldring, C, Hay, D C, Healy, L, Hows, A, Hutchinson, C, Jesson, H, Kalber, T, Kimber, S, Leathers, R, Moyle, S, Murray, T, Neale, M, Pan, D, Park, B K, Rebolledo, R E, Rees, I, Rivolta, M N, Ritchie, A, Roos, E J, Saeb-Parsy, K, Schröder, B, Sebastien, S, Thomas, A, Thomas, R J, Turner, M, Vallier, L, Vitillo, L, Webster, A & Williams, D 2018, ' Science-based assessment of source materials for cell-based medicines : Report of a stakeholders workshop ', Regenerative Medicine, vol. 13, no. 8, pp. 935-944 . https://doi.org/10.2217/rme-2018-0120
Stacey, G, Andrews, P, Asante, C, Barbaric, I, Barry, J, Bisset, L, Braybrook, J, Buckle, R, Chandra, A, Coffey, P, Crouch, S, Driver, P, Evans, A, Gardner, J, Ginty, P, Goldring, C, Hay, D C, Healy, L, Hows, A, Hutchinson, C, Jesson, H, Kalber, T, Kimber, S, Leathers, R, Moyle, S, Murray, T, Neale, M, Pan, D, Park, B K, Rebolledo, R E, Rees, I, Rivolta, M N, Ritchie, A, Roos, E J, Saeb-parsy, K, Schröder, B, Sebastien, S, Thomas, A, Thomas, R J, Turner, M, Vallier, L, Vitillo, L, Webster, A & Williams, D 2018, ' Science-based assessment of source materials for cell-based medicines: report of a stakeholders workshop ', Regenerative medicine, vol. 13, no. 8, pp. 935-944 . https://doi.org/10.2217/rme-2018-0120
Stacey, G, Andrews, P, Asante, C, Barbaric, I, Barry, J, Bisset, L, Braybrook, J, Buckle, R, Chandra, A, Coffey, P, Crouch, S, Driver, P, Evans, A, Gardner, J, Ginty, P, Goldring, C, Hay, D C, Healy, L, Hows, A, Hutchinson, C, Jesson, H, Kalber, T, Kimber, S, Leathers, R, Moyle, S, Murray, T, Neale, M, Pan, D, Park, B K, Rebolledo, R E, Rees, I, Rivolta, M N, Ritchie, A, Roos, E J, Saeb-parsy, K, Schröder, B, Sebastien, S, Thomas, A, Thomas, R J, Turner, M, Vallier, L, Vitillo, L, Webster, A & Williams, D 2018, ' Science-based assessment of source materials for cell-based medicines: report of a stakeholders workshop ' vol. 13, no. 8, pp. 935-944 . DOI: 10.2217/rme-2018-0120
REGENERATIVE MEDICINE
ISSN: 1746-076X
1746-0751
DOI: 10.2217/rme-2018-0120
Popis: 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.
Databáze: OpenAIRE
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