ArticleStem cell reports2026
Toward standardized iPSC testing: Insights from a multi-year international Quality Assessment Round.
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Article in Stem cell reports, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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2citing papers in PubMed
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2 citing papers in PubMed.
- Review
- Induced pluripotent stem cells as platforms for engineering NK cell immunotherapies.Frontiers in cell and developmental biology · 2026Review
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Authors and funding
84 authors.
Alice HäggDepartment of Experimental Medical Science (EMV), Lund Stem Cell Center, Science for Life Laboratory, Sölvegatan 17 A11, 221 84 Lund, Sweden.
Rachel WoodScottish National Blood Transfusion Service, The Jack Copland Centre, 52 Research Avenue North, Heriot-Watt Research Park, Edinburgh EH14 4BE, UK.
Ayako L MochizukiCiRA Foundation, 53 Shogoin kawahara-cho, Sakyo-ku, Kyoto 606-8397, Japan.
Keren AbbertonStem Cell Medicine, Murdoch Children's Research Institute, 50 Flemington Rd, Parkville, VIC 3052, Australia.
Elsa AbranchesUK Stem Cell Bank, Medicines and Healthcare Products Regulatory Agency (MHRA), South Mimms Campus, Blanche Lane, South Mimms, Hertfordshire EN6 3QG, UK.
Belén Alvarez-PalomoBanc de Sang i Teixits, Barcelona, Spain.
Ricardo BaptistaSmartCella, Alfred Nobels Allé 150, 146 48 Tullinge-Stockholm, Sweden.
Raiana Andrade Quintanilha BarbosaResearch Center for Precision Medicine, Carlos Chagas Filho Biophysics Institute Federal University of Rio de Janeiro, Rua Carlos Chagas Filho 373, Ilha do Fundão, Rio de Janeiro, RJ 21941-902, Brazil.
Jacqueline BarryCell and Gene Therapy Catapult, 12th Floor Tower Wing, Guy's Hospital, Great Maze Pond, London SE1 9RT, UK.
Adriana Bastos CarvalhoResearch Center for Precision Medicine, Carlos Chagas Filho Biophysics Institute Federal University of Rio de Janeiro, Rua Carlos Chagas Filho 373, Ilha do Fundão, Rio de Janeiro, RJ 21941-902, Brazil.
Annelise Bennaceur GriscelliUniversity Paris-Saclay, INSERM, UMS 45 CITHERA - Center for iPS Cell Therapies, National Infrastructure INGESTEM, Paris, France.
Antonio Carlos Campos de CarvalhoResearch Center for Precision Medicine, Carlos Chagas Filho Biophysics Institute Federal University of Rio de Janeiro, Rua Carlos Chagas Filho 373, Ilha do Fundão, Rio de Janeiro, RJ 21941-902, Brazil.
Diana ChakerUniversity Paris-Saclay, INSERM, UMS 45 CITHERA - Center for iPS Cell Therapies, National Infrastructure INGESTEM, Paris, France.
Hong ChangCenter for Commericialization of Regenerative Medicine (CCRM), #1002, 661 University Ave, Toronto, ON M5G 1M1, Canada.
Hye Young ChoiNational Center for Stem Cell and Regenerative Medicine, National Institute of Health, 202 Osongsaengmyeong2-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do 28160, South Korea.
Margarita CodinachBanc de Sang i Teixits, Barcelona, Spain.
Begoña Arán CorbellaBarcelona Stem Cell Bank, Regenerative Medicine Program, Institut d'Investigació Biomèdica, IDIBELL, P-CMR[C]-Program of Translation of Regenerative Medicine in Catalonia, Catalonia, Spain.
Scott CowanScottish National Blood Transfusion Service, The Jack Copland Centre, 52 Research Avenue North, Heriot-Watt Research Park, Edinburgh EH14 4BE, UK.
Sarah Jane DickersonFUJIFILM Cellular Dynamics Inc, Madison, WI 53711, USA.
Ngaire ElwoodStem Cell Medicine, Murdoch Children's Research Institute, 50 Flemington Rd, Parkville, VIC 3052, Australia; Department of Paediatrics, University of Melbourne, Parkville, VIC 3052, Australia.
Xueling FanCenter for Commericialization of Regenerative Medicine (CCRM), #1002, 661 University Ave, Toronto, ON M5G 1M1, Canada.
Maxime FeyeuxTreeFrog Therapeutics, 30 Av. Gustave Eiffel Bâtiment A, 33600 Pessac, France.
Maddy ForresterSTEMCELL Technologies, 1618 Station St, Vancouver, BC V6A 1B6, Canada.
Andrew GaffneySTEMCELL Technologies, 1618 Station St, Vancouver, BC V6A 1B6, Canada.
Solenn M GuilbertTreeFrog Therapeutics, 30 Av. Gustave Eiffel Bâtiment A, 33600 Pessac, France.
Hye-Yeong HaNational Center for Stem Cell and Regenerative Medicine, National Institute of Health, 202 Osongsaengmyeong2-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do 28160, South Korea.
Adam J HirstSTEMCELL Technologies, 1618 Station St, Vancouver, BC V6A 1B6, Canada.
Arwen L HunterSTEMCELL Technologies, 1618 Station St, Vancouver, BC V6A 1B6, Canada.
Leanne G JamiesonBlueRock Therapeutics (2019) and Notch Therapeutics (2023/2024), Toronto, ON, Canada.
Robert N JudsonSTEMCELL Technologies, 1618 Station St, Vancouver, BC V6A 1B6, Canada.
Yonehiro KanemuraDepartment of Biomedical Research and Innovation, Institute for Clinical Research, NHO Osaka National Hospital, Osaka 540-0006, Japan.
Tais Hanae Kasai-BrunswickResearch Center for Precision Medicine, Carlos Chagas Filho Biophysics Institute Federal University of Rio de Janeiro, Rua Carlos Chagas Filho 373, Ilha do Fundão, Rio de Janeiro, RJ 21941-902, Brazil.
Jung-Hyun KimNational Center for Stem Cell and Regenerative Medicine, National Institute of Health, 202 Osongsaengmyeong2-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do 28160, South Korea.
Howard KimNew York Stem Cell Foundation Research Institute, 619 West 54th Street, New York, NY 10019, USA.
Manisha KintaliNew York Stem Cell Foundation Research Institute, 619 West 54th Street, New York, NY 10019, USA.
Siddharth KrishnanCell and Gene Therapy Catapult, 12th Floor Tower Wing, Guy's Hospital, Great Maze Pond, London SE1 9RT, UK.
Bernd KueblerBarcelona Stem Cell Bank, Regenerative Medicine Program, Institut d'Investigació Biomèdica, IDIBELL, P-CMR[C]-Program of Translation of Regenerative Medicine in Catalonia, Catalonia, Spain.
Chui Yu LauCentury Therapeutics, 3624 Market Street, #5 Floor West, Philadelphia, PA 19104, USA.
Wilson LiCell and Gene Therapy Catapult, 12th Floor Tower Wing, Guy's Hospital, Great Maze Pond, London SE1 9RT, UK.
Amanda MackDark Horse Consulting Group, 1255 Treat Blvd # 230, Walnut Creek, CA 94597, USA.
Michael R MacLeodCenter for Commericialization of Regenerative Medicine (CCRM), #1002, 661 University Ave, Toronto, ON M5G 1M1, Canada.
Marinna MadridCellino, 750 Main St, Cambridge, MA 02139, USA.
Hiroaki MamiyaCollege of Pharmaceutical Sciences, Ritsumeikan University, 1-1-1 Noji-Higashi, Kusatsu, Shiga 525-8577, Japan.
Lucie Manache-AlbericiTreeFrog Therapeutics, 30 Av. Gustave Eiffel Bâtiment A, 33600 Pessac, France.
Dragoş MărgineanCell and Gene Therapy Catapult, 12th Floor Tower Wing, Guy's Hospital, Great Maze Pond, London SE1 9RT, UK.
Olivier MentreCenter for Commericialization of Regenerative Medicine (CCRM), #1002, 661 University Ave, Toronto, ON M5G 1M1, Canada.
Stefanie L MorganCellino, 750 Main St, Cambridge, MA 02139, USA.
Joanne MountfordScottish National Blood Transfusion Service, The Jack Copland Centre, 52 Research Avenue North, Heriot-Watt Research Park, Edinburgh EH14 4BE, UK.
Humayun MunirNew York Stem Cell Foundation Research Institute, 619 West 54th Street, New York, NY 10019, USA.
Siemon H S NgNotch Therapeutics, Toronto, ON, Canada.
Haruna OgawaCiRA Foundation, 53 Shogoin kawahara-cho, Sakyo-ku, Kyoto 606-8397, Japan.
Steve OhStem Cell Group, Bioprocessing Technology Institute, A∗STAR, Singapore, Singapore.
Hidetaka OharaSumitomo Pharma Co., Ltd., 33-94, Enoki-cho, Suita, Osaka 564-0053, Japan.
Keiko OonoCiRA Foundation, 53 Shogoin kawahara-cho, Sakyo-ku, Kyoto 606-8397, Japan.
Niall ParkScottish National Blood Transfusion Service, The Jack Copland Centre, 52 Research Avenue North, Heriot-Watt Research Park, Edinburgh EH14 4BE, UK.
Lygia V PereiraNational Laboratory for Embryonic Stem Cells (LaNCE), Department of Genetics and Evolutionary Biology, Institute of Biosciences, University of São Paulo, São Paulo, SP 05508-090, Brazil.
Izabella Pereira da Silva BezerraResearch Center for Precision Medicine, Carlos Chagas Filho Biophysics Institute Federal University of Rio de Janeiro, Rua Carlos Chagas Filho 373, Ilha do Fundão, Rio de Janeiro, RJ 21941-902, Brazil.
Alexandru Robert PodoveiCell and Gene Therapy Catapult, 12th Floor Tower Wing, Guy's Hospital, Great Maze Pond, London SE1 9RT, UK.
Sergio QuerolJosep Carreras Leukaemia Foundation, Muntaner 383, 2nd, 08021 Barcelona, Spain.
Jainy RajeBlueRock Therapeutics, Toronto, ON, Canada.
Angel RayaICREA, Regenerative Medicine Program, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), P-CMR[C]-Program of Translation of Regenerative Medicine in Catalonia, Center for Networked Biomedical Research on Bioengineering, Biomaterials and Nanomedicine (CIBER-BBN), Physiological Sciences Department, University of Barcelona, Barcelona, Spain.
Satoko SakamotoSumitomo Pharma Co., Ltd., 33-94, Enoki-cho, Suita, Osaka 564-0053, Japan.
Raquel SarafianNational Laboratory for Embryonic Stem Cells (LaNCE), Department of Genetics and Evolutionary Biology, Institute of Biosciences, University of São Paulo, São Paulo, SP 05508-090, Brazil.
Kathleen SchmitTreeFrog Therapeutics, 30 Av. Gustave Eiffel Bâtiment A, 33600 Pessac, France.
Silvia SelvitellaBarcelona Stem Cell Bank, Regenerative Medicine Program, Institut d'Investigació Biomèdica, IDIBELL, P-CMR[C]-Program of Translation of Regenerative Medicine in Catalonia, Catalonia, Spain.
Gurbind SinghCentre for Stem Cell Research (a unit of BRIC-inStem, Bengaluru), Christian Medical College Campus, Bagayam, Vellore, Tamil Nadu 632002, India.
Matthew J K SmartCell and Gene Therapy Catapult, 12th Floor Tower Wing, Guy's Hospital, Great Maze Pond, London SE1 9RT, UK.
Jihwan SongCHA University, Rm 604, CHA Bio Complex, 335 Pangyo-ro, Bundang-gu, Seongnam-si, Gyeonggi-do 13488, Republic of Korea.
Glyn StaceyInternational Stem Cell Biobanking Initiative, Barley, Hertfordshire SG88HZ, UK; National Stem Cell Resource Centre, Institute of Zoology, Chinese Academy of Sciences, Beijing 100190, China; Beijing Institute for Stem Cell Regenerative Medicine and Chinese Academy of Sciences, Beijing 100101, China.
Stephen SullivanLindville Bio, 69 Warrender Park Road, Edinburgh, UK.
Miho SumidaDepartment of Biomedical Research and Innovation, Institute for Clinical Research, NHO Osaka National Hospital, Osaka 540-0006, Japan.
Cecile TerrenoireNew York Stem Cell Foundation Research Institute, 619 West 54th Street, New York, NY 10019, USA.
Pei TianStem Cell Medicine, Murdoch Children's Research Institute, 50 Flemington Rd, Parkville, VIC 3052, Australia.
Elias UhlinDepartment of Experimental Medical Science (EMV), Lund Stem Cell Center, Science for Life Laboratory, Sölvegatan 17 A11, 221 84 Lund, Sweden.
José M A VaqueroBarcelona Stem Cell Bank, Regenerative Medicine Program, Institut d'Investigació Biomèdica, IDIBELL, P-CMR[C]-Program of Translation of Regenerative Medicine in Catalonia, Catalonia, Spain.
Anna VeigaBarcelona Stem Cell Bank, Regenerative Medicine Program, Institut d'Investigació Biomèdica, IDIBELL, P-CMR[C]-Program of Translation of Regenerative Medicine in Catalonia, Catalonia, Spain.
Jar Wei Vicky WangSTEMCELL Technologies, 1618 Station St, Vancouver, BC V6A 1B6, Canada.
Katherine Warre-CornishMedicines and Healthcare products Regulatory Agency, London, UK.
Jamie WoodFormerly Medicines and Healthcare Products Regulatory Agency, London, UK.
Atsuyo YamamotoDepartment of Biomedical Research and Innovation, Institute for Clinical Research, NHO Osaka National Hospital, Osaka 540-0006, Japan.
Gaojun ZhangCenter for Commericialization of Regenerative Medicine (CCRM), #1002, 661 University Ave, Toronto, ON M5G 1M1, Canada.
Takafusa HikichiCiRA Foundation, 53 Shogoin kawahara-cho, Sakyo-ku, Kyoto 606-8397, Japan.
Marc TurnerScottish National Blood Transfusion Service, The Jack Copland Centre, 52 Research Avenue North, Heriot-Watt Research Park, Edinburgh EH14 4BE, UK. Electronic address: marc.turner2@nhs.scot.
Anna FalkDepartment of Experimental Medical Science (EMV), Lund Stem Cell Center, Science for Life Laboratory, Sölvegatan 17 A11, 221 84 Lund, Sweden. Electronic address: anna.falk@med.lu.se.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
Indexed as
Induced Pluripotent Stem CellsBiomarkersCell DifferentiationFlow CytometryHumansQuality ControlBiomarkerscell therapy manufacturingflow cytometrygenomic integrityglobal harmonizationinduced pluripotent stem cellsinter-laboratory reproducibilityqPCRquality controlregenerative medicinestandardization
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