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DOI 10.1016/j.stemcr.2026.102857

Медицинская библиотека · Stem cell reports · 2026

Toward standardized iPSC testing: Insights from a multi-year international Quality Assessment Round.

Hägg Alice, Wood Rachel, Mochizuki Ayako L, Abberton Keren, Abranches Elsa, Alvarez-Palomo Belén, Baptista Ricardo, Quintanilha Barbosa Raiana Andrade, Barry Jacqueline, Carvalho Adriana Bastos, Bennaceur Griscelli Annelise, Campos de Carvalho Antonio Carlos, Chaker Diana, Chang Hong, Choi Hye Young, Codinach Margarita, Arán Corbella Begoña, Cowan Scott, Dickerson Sarah Jane, Elwood Ngaire, Fan Xueling, Feyeux Maxime, Forrester Maddy, Gaffney Andrew, Guilbert Solenn M, Ha Hye-Yeong, Hirst Adam J, Hunter Arwen L, Jamieson Leanne G, Judson Robert N, Kanemura Yonehiro, Kasai-Brunswick Tais Hanae, Kim Jung-Hyun, Kim Howard, Kintali Manisha, Krishnan Siddharth, Kuebler Bernd, Lau Chui Yu, Li Wilson, Mack Amanda, MacLeod Michael R, Madrid Marinna, Mamiya Hiroaki, Manache-Alberici Lucie, Mărginean Dragoş, Mentre Olivier, Morgan Stefanie L, Mountford Joanne, Munir Humayun, Ng Siemon H S, Ogawa Haruna, Oh Steve, Ohara Hidetaka, Oono Keiko, Park Niall, Pereira Lygia V, Pereira da Silva Bezerra Izabella, Podovei Alexandru Robert, Querol Sergio, Raje Jainy, Raya Angel, Sakamoto Satoko, Sarafian Raquel, Schmit Kathleen, Selvitella Silvia, Singh Gurbind, Smart Matthew J K, Song Jihwan, Stacey Glyn, Sullivan Stephen, Sumida Miho, Terrenoire Cecile, Tian Pei, Uhlin Elias, Vaquero José M A, Veiga Anna, Vicky Wang Jar Wei, Warre-Cornish Katherine, Wood Jamie, Yamamoto Atsuyo, Zhang Gaojun, Hikichi Takafusa, Turner Marc, Falk Anna

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Аннотация

Despite rapid clinical translation, induced pluripotent stem cell (iPSC)-derived therapies face limited global adoption. Harmonized quality control (QC) remains absent, with even fundamental parameters evaluated inconsistently across laboratories. To address this, we conducted two international Quality Assessment Rounds (QARs): QAR 2019 (18 sites, 11 countries) and QAR 2023 (23 sites, 12 countries), evaluating flow cytometry-based assessment of the undifferentiated state and qPCR-based genomic integrity testing. QAR 2019 showed high consistency in genomic integrity testing, while uncovering substantial variability in flow cytometry, prompting QAR 2023 to introduce standardized workflows. These improvements enabled systematic, cross-site evaluation of marker performance across cell states, identifying OCT3/4, TRA-1-60, and SSEA5 as consistently robust pluripotency-associated markers. This global benchmarking effort provides the first empirical multi-site evidence for reproducible iPSC QC and marker-level reliability. Together, these findings establish a foundation for harmonized QC supporting interoperable iPSC banks, regulatory alignment, and scalable manufacturing of globally accessible regenerative therapies.

Для цитирования: Hägg Alice, Wood Rachel, Mochizuki Ayako L, Abberton Keren, Abranches Elsa, Alvarez-Palomo Belén, Baptista Ricardo, Quintanilha Barbosa Raiana Andrade, Barry Jacqueline, Carvalho Adriana Bastos, Bennaceur Griscelli Annelise, Campos de Carvalho Antonio Carlos, Chaker Diana, Chang Hong, Choi Hye Young, Codinach Margarita, Arán Corbella Begoña, Cowan Scott, Dickerson Sarah Jane, Elwood Ngaire, Fan Xueling, Feyeux Maxime, Forrester Maddy, Gaffney Andrew, Guilbert Solenn M, Ha Hye-Yeong, Hirst Adam J, Hunter Arwen L, Jamieson Leanne G, Judson Robert N, Kanemura Yonehiro, Kasai-Brunswick Tais Hanae, Kim Jung-Hyun, Kim Howard, Kintali Manisha, Krishnan Siddharth, Kuebler Bernd, Lau Chui Yu, Li Wilson, Mack Amanda, MacLeod Michael R, Madrid Marinna, Mamiya Hiroaki, Manache-Alberici Lucie, Mărginean Dragoş, Mentre Olivier, Morgan Stefanie L, Mountford Joanne, Munir Humayun, Ng Siemon H S, Ogawa Haruna, Oh Steve, Ohara Hidetaka, Oono Keiko, Park Niall, Pereira Lygia V, Pereira da Silva Bezerra Izabella, Podovei Alexandru Robert, Querol Sergio, Raje Jainy, Raya Angel, Sakamoto Satoko, Sarafian Raquel, Schmit Kathleen, Selvitella Silvia, Singh Gurbind, Smart Matthew J K, Song Jihwan, Stacey Glyn, Sullivan Stephen, Sumida Miho, Terrenoire Cecile, Tian Pei, Uhlin Elias, Vaquero José M A, Veiga Anna, Vicky Wang Jar Wei, Warre-Cornish Katherine, Wood Jamie, Yamamoto Atsuyo, Zhang Gaojun, Hikichi Takafusa, Turner Marc, Falk Anna. Toward standardized iPSC testing: Insights from a multi-year international Quality Assessment Round.. Stem cell reports. 2026. DOI: 10.1016/j.stemcr.2026.102857.

Предметные рубрики MeSH

Induced Pluripotent Stem CellsHumansQuality ControlFlow CytometryCell DifferentiationBiomarkers
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