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DOI 10.1016/j.stemcr.2025.102784

Медицинская библиотека · Stem cell reports · 2026

Charting the translational pathway: ISSCR best practices for the development of PSC-derived therapies.

Barry Jacqueline, Abranches Elsa, Baptista Ricardo P, Barry Chris, Brandsten Catharina, Bruce Kevin, Carpenter Melissa K, Cavagnaro Joy, Collins Lila, Csaszar Elizabeth, Dashnau Jennifer, de Villa Denise, Fynes Kate, Gabaldo Michela, Hao Jie, Harel-Adar Tamar, Hei Derek, Henchcliffe Claire, Hidalgo-Simon Ana, Hollands Jennifer, Hursh Deborah, Jackman Shawna, Kelly Kilian, Kim Jung-Hyun, Kim Hyunyoung, Kino-Oka Masahiro, Lakshmipathy Uma, Lamb Tyler, Lazic Stanley E, Loring Jeanne F, Ludwig Tenneille E, Mariappan Indumathi, Monville Christelle, Mountford Joanne C, Nagy Andras, Okano Hideyuki, Pellegrini Graziella, Persson Annelie, Prutton Kendra, Rasko John E J, Sareen Dhruv, Sato Yoji, Shnaiderman Anat, Stacey Glyn, Svendsen Clive N, Tomishima Mark, Trounson Alan, Viswanathan Sowmya, Wang Shuyan, Wydenbach Kirsty, Zhang Alex, Zylberberg Claudia, Mosher Jack T, Bharti Kapil

СтатьяОбзорПоддержка исследования: вне правительства СШАПеревод в очереди

Аннотация

The successful translation of a stem cell-derived product from the laboratory into an approved medicine requires specific scientific, technical, and regulatory understanding. Since this knowledge base is fragmented across websites and publications, the ISSCR has developed a new resource, The Best Practices for the Development of Pluripotent Stem Cell-Derived Therapies. This comprehensive, interactive document, designed for academia and industry, addresses critical areas of the translational pipeline and key decision points for the successful translation to a licensed therapy. Uniquely, it provides a global perspective of the regulatory landscape while providing resources for critical processes and links to jurisdictional regulatory information.

Для цитирования: Barry Jacqueline, Abranches Elsa, Baptista Ricardo P, Barry Chris, Brandsten Catharina, Bruce Kevin, Carpenter Melissa K, Cavagnaro Joy, Collins Lila, Csaszar Elizabeth, Dashnau Jennifer, de Villa Denise, Fynes Kate, Gabaldo Michela, Hao Jie, Harel-Adar Tamar, Hei Derek, Henchcliffe Claire, Hidalgo-Simon Ana, Hollands Jennifer, Hursh Deborah, Jackman Shawna, Kelly Kilian, Kim Jung-Hyun, Kim Hyunyoung, Kino-Oka Masahiro, Lakshmipathy Uma, Lamb Tyler, Lazic Stanley E, Loring Jeanne F, Ludwig Tenneille E, Mariappan Indumathi, Monville Christelle, Mountford Joanne C, Nagy Andras, Okano Hideyuki, Pellegrini Graziella, Persson Annelie, Prutton Kendra, Rasko John E J, Sareen Dhruv, Sato Yoji, Shnaiderman Anat, Stacey Glyn, Svendsen Clive N, Tomishima Mark, Trounson Alan, Viswanathan Sowmya, Wang Shuyan, Wydenbach Kirsty, Zhang Alex, Zylberberg Claudia, Mosher Jack T, Bharti Kapil. Charting the translational pathway: ISSCR best practices for the development of PSC-derived therapies.. Stem cell reports. 2026. DOI: 10.1016/j.stemcr.2025.102784.

Предметные рубрики MeSH

Pluripotent Stem CellsHumansTranslational Research, BiomedicalAnimals
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