International Evaluation Study of a Highly Efficient Culture Assay for Detection of Residual Human Pluripotent Stem Cells in Cell Therapies

References

• Sato Y , BandoH , DiPiazza Met al. Tumorigenicity assessment of cell therapy products: the need for global consensus and points to consider. Cytotherapy21(11), 1095–1111 (2019).
   PubMed Web of Science ®Google Scholar
• Yamanaka S . Pluripotent stem cell-based cell therapy – promise and challenges. Cell. Stem Cell.27(4), 523–531 (2020).
   PubMed Web of Science ®Google Scholar
• Kanemura H , GoMJ , ShikamuraMet al. Tumorigenicity studies of induced pluripotent stem cell (iPSC)-derived retinal pigment epithelium (RPE) for the treatment of age-related macular degeneration. PLOS ONE9(1), e85336 (2014).
   PubMed Web of Science ®Google Scholar
• Kooreman NG , WuJC. Tumorigenicity of pluripotent stem cells: biological insights from molecular imaging. J. R. Soc. Interface.7(Suppl. 6), S753–S763 (2010).
   PubMedGoogle Scholar
• Bedel A , BeliveauF , Lamrissi-GarciaIet al. Preventing pluripotent cell teratoma in regenerative medicine applied to hematology disorders. Stem Cells Transl. Med.6(2), 382–393 (2016).
   PubMed Web of Science ®Google Scholar
• Tohyama S , FukudaK. Future treatment of heart failure using human iPSC-derived cardiomyocytes. In: Etiology and Morphogenesis of Congenital Heart Disease: From Gene Function and Cellular Interaction to Morphology.NakanishiT, MarkwaldRR, BaldwinHS, KellerBB, SrivastavaD, YamagishiH ( Eds). Springer, Tokyo, Japan (2016).
   Google Scholar
• Chung L , CogburnLA , SuiL , DashnauJL. Development of an induced pluripotent stem cell-specific microRNA assay for detection of residual undifferentiated cells in natural killer cell therapy products. Cytotherapy24(7), 733–741 (2022).
   PubMed Web of Science ®Google Scholar
• Bando H , DiPiazza M , GowingGet al. Safety of cell therapy products: in-vitro methods to assess the tumorigenicity of human cell-based therapeutic products. Cytotherapy22(5), S42 (2022).
   Web of Science ®Google Scholar
• Kuroda T , YasudaS , KusakawaSet al. Highly sensitive in vitro methods for detection of residual undifferentiated cells in retinal pigment epithelial cells derived from human iPS cells. PLOS ONE7(5), e37342 (2012).
   PubMed Web of Science ®Google Scholar
• Tateno H , OnumaY , ItoYet al. A medium hyperglycosylated podocalyxin enables noninvasive and quantitative detection of tumorigenic human pluripotent stem cells. Sci. Rep.4, 4069 (2014).
   PubMed Web of Science ®Google Scholar
• Kuroda T , YasudaS , MatsuyamaSet al. Highly sensitive droplet digital PCR method for detection of residual undifferentiated cells in cardiomyocytes derived from human pluripotent stem cells. Regen. Ther.2, 17–23 (2015).
   PubMed Web of Science ®Google Scholar
• Sekine K , TsuzukiS , YasuiRet al. Robust detection of undifferentiated iPSC among differentiated cells. Sci. Rep.10, 10293 (2020).
   PubMed Web of Science ®Google Scholar
• Tano K , YasudaS , KurodaT , SaitoH , UmezawaA , SatoY. A novel in vitro method for detecting undifferentiated human pluripotent stem cells as impurities in cell therapy products using a highly efficient culture system. PlOS ONE9(10), e110496 (2014).
   PubMed Web of Science ®Google Scholar
• Watanabe T , YasudaS , KusakawaSet al. Multisite studies for validation and improvement of a highly efficient culture assay for detection of undifferentiated human pluripotent stem cells intermingled in cell therapy products. Cytotherapy23(2), 176–183 (2021).
   PubMed Web of Science ®Google Scholar
• Yasui R , MatsuiA , SekineK , OkamotoS , TaniguchiH. Highly sensitive detection of human pluripotent stem cells by loop-mediated isothermal amplification. Stem. Cell. Rev. Rep.18(8), 2995–3007 (2022).
   PubMed Web of Science ®Google Scholar
• Chen Y , TristanCA , ChenLet al. A versatile polypharmacology platform promotes cytoprotection and viability of human pluripotent and differentiated cells. Nat. Methods.18, 528–541 (2021).
   PubMed Web of Science ®Google Scholar
• ISO/TS 17822-1:2014 . In vitro diagnostic test systems – qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens – part 1: general requirements, terms and definitions (December 2014)(2014). (Accessed 30June2020). www.iso.org/standard/60601.html
   Google Scholar
• International Organization for Standardization (ISO) . Accuracy (trueness and precision) of measurement methods and results – part 2: basic method for the determination of repeatability and reproducibility of a standard measurement method. ISO 5725-2:2019; Geneva, Switzerland(2019). www.iso.org/standard/69419.html
   Google Scholar
• Luping T , SchouenborgB. Methodology of inter-comparison tests and statistical analysis of the test results – Nordtest project no. 1483-1499. www.diva-portal.org/smash/get/diva2:962159/FULLTEXT01.pdf
   Google Scholar
• International Organization for Standardization (ISO) . Statistics – vocabulary and symbols – part 1: general statistical terms and terms used in probability. ISO, Geneva, Switzerland, 3534–1 (2006). www.iso.org/standard/40145.html
   Google Scholar
• Peterson SE , GaritaonandiaI , LoringJF. The tumorigenic potential of pluripotent stem cells: what can we do to minimize it?BioEssays38(Suppl. 1), S86–S95 (2016).
   PubMedGoogle Scholar
• Garitaonandia I , GonzalezR , Christiansen-WeberT , AbramihinaT , PoustovoitovM , NoskovAet al. Neural stem cell tumorigenicity and biodistribution assessment for phase I clinical trial in Parkinson’s disease. Sci. Rep.6, 34478 (2016).
   PubMed Web of Science ®Google Scholar
• International Conference on Harmonization . Q2(R1): Validation of analytical procedures: text and methodology. (Accessed 26December2022). https://database.ich.org/sites/default/files/Q2%28R1%29%20Guideline.pdf
   Google Scholar
• Yasuda S , KusakawaS , KurodaTet al. Tumorigenicity-associated characteristics of human iPS cell lines. PL0S ONE13(10), e0205022 (2018).
   PubMed Web of Science ®Google Scholar
• Chen G , HouZ , GulbransonDR , ThomsonJA. Actin–myosin contractility is responsible for the reduced viability of dissociated human embryonic stem cells. Cell. Stem. Cell.7(2), 240–248 (2010).
   PubMed Web of Science ®Google Scholar
• Ohgushi M , MatsumuraM , EirakuMet al. Molecular pathway and cell state responsible for dissociation-induced apoptosis in human pluripotent stem cells. Cell. Stem. Cell.7(2), 225–239 (2010).
   PubMed Web of Science ®Google Scholar
• Xu Y , ZhuX , HahmHSet al. Revealing a core signaling regulatory mechanism for pluripotent stem cell survival and self-renewal by small molecules. Proc. Natl Acad. Sci. USA107(18), 8129–8134 (2010).
   PubMed Web of Science ®Google Scholar
• Watanabe K , UenoM , KamiyaDet al. A ROCK inhibitor permits survival of dissociated human embryonic stem cells. Nat. Biotechnol.25, 681–686 (2007).
   PubMed Web of Science ®Google Scholar
• Kawamata S , KanemuraH , SakaiN , TakahashiM , GoMJ. Design of a tumorigenicity test for induced pluripotent stem cell (iPSC)-derived cell products. J. Clin. Med.4(1), 159–171 (2015).
   PubMed Web of Science ®Google Scholar