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Abstract：
UNASSIGNED: MEASURE2 (Multisite Evaluation Study on Analytical Methods for Non-clinical Safety Assessment of HUman-derived REgenerative Medical Products 2) is a Japanese experimental public-private partnership initiative that aims to standardize testing methods for tumorigenicity evaluation of human pluripotent stem cell (hPSC)-derived cell therapy products (CTPs). MEASURE2 organized multisite studies to optimize the methodology of the highly efficient culture (HEC) assay, a sensitive culture-based in vitro assay for detecting residual undifferentiated hPSCs in CTPs.
UNASSIGNED: In these multisite studies, 1) the efficiency of colony formation by human induced pluripotent stem cells (hiPSCs) under two different culture conditions and 2) the sorting efficiency of microbeads conjugated to various anti-hPSC markers during hiPSC enrichment were evaluated using samples in which hiPSCs were spiked into hiPSC-derived mesenchymal stem cells.
UNASSIGNED: The efficiency of colony formation was significantly higher under culture conditions with the combination of Chroman 1, Emricasan, Polyamines, and Trans-ISRIB (CEPT) than with Y-27632, which is widely used for the survival of hPSCs. Between-laboratory variance was also smaller under the condition with CEPT than with Y-27632. The sorting efficiency of microbeads conjugated with the anti-Tra-1-60 antibody was sufficiently higher (>80%) than those of the other various microbeads investigated.
UNASSIGNED: Results of these multisite studies are expected to contribute to improvements in the sensitivity and robustness of the HEC assay, as well as to the future standardization of the tumorigenicity risk assessment of hPSC-derived CTPs.
UNASSIGNED: In these multisite studies, 1) the efficiency of colony formation by human induced pluripotent stem cells (hiPSCs) under two different culture conditions and 2) the sorting efficiency of microbeads conjugated to various anti-hPSC markers during hiPSC enrichment were evaluated using samples in which hiPSCs were spiked into hiPSC-derived mesenchymal stem cells.
UNASSIGNED: The efficiency of colony formation was significantly higher under culture conditions with the combination of Chroman 1, Emricasan, Polyamines, and Trans-ISRIB (CEPT) than with Y-27632, which is widely used for the survival of hPSCs. Between-laboratory variance was also smaller under the condition with CEPT than with Y-27632. The sorting efficiency of microbeads conjugated with the anti-Tra-1-60 antibody was sufficiently higher (>80%) than those of the other various microbeads investigated.
UNASSIGNED: Results of these multisite studies are expected to contribute to improvements in the sensitivity and robustness of the HEC assay, as well as to the future standardization of the tumorigenicity risk assessment of hPSC-derived CTPs.
摘要：
■MEASURE2（HUman衍生的再生医疗产品2的非临床安全性评估分析方法的多部位评估研究）是日本的一项实验性公私合作计划，旨在标准化致瘤性评估的测试方法人类多能干细胞（hPSC）衍生的细胞治疗产品（CTP）。MEASURE2组织了多位点研究，以优化高效培养（HEC）测定的方法，一种灵敏的基于培养的体外检测方法，用于检测CTP中残留的未分化hPSC。
■在这些多点研究中，1）在两种不同的培养条件下，人诱导多能干细胞（hiPSC）的集落形成效率和2）使用将hiPSC掺入hiPSC衍生的间充质干细胞的样品评估hiPSC富集过程中与各种抗hPSC标记物缀合的微珠的分选效率。
■在使用Chroman1，Emricasan，多胺,和Trans-ISRIB(CEPT)比Y-27632,其广泛用于hPSC的存活。CEPT条件下的实验室间差异也小于Y-27632。与抗Tra-1-60抗体缀合的微珠的分选效率充分高于(>80%)所研究的其他各种微珠的分选效率。
■这些多点研究的结果预计将有助于改善HEC测定的灵敏度和稳健性，以及hPSC衍生的CTP的致瘤性风险评估的未来标准化。
■在这些多点研究中，1）在两种不同的培养条件下，人诱导多能干细胞（hiPSC）的集落形成效率和2）使用将hiPSC掺入hiPSC衍生的间充质干细胞的样品评估hiPSC富集过程中与各种抗hPSC标记物缀合的微珠的分选效率。
■在使用Chroman1，Emricasan，多胺,和Trans-ISRIB(CEPT)比Y-27632,其广泛用于hPSC的存活。CEPT条件下的实验室间差异也小于Y-27632。与抗Tra-1-60抗体缀合的微珠的分选效率充分高于(>80%)所研究的其他各种微珠的分选效率。
■这些多点研究的结果预计将有助于改善HEC测定的灵敏度和稳健性，以及hPSC衍生的CTP的致瘤性风险评估的未来标准化。
