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.
Cytotherapy
; 23(2): 176-183, 2021 02.
Article
en En
| MEDLINE
| ID: mdl-32978066
ABSTRACT
BACKGROUND AIMS:
The Multisite Evaluation Study on Analytical Methods for Non-Clinical Safety Assessment of Human-Derived Regenerative Medical Products (MEASURE) is a Japanese experimental public-private partnership initiative, which aims to standardize methodology for tumorigenicity evaluation of human pluripotent stem cell (hPSC)-derived cell therapy products (CTPs). Undifferentiated hPSCs possess tumorigenic potential, and thus residual undifferentiated hPSCs are one of the major hazards for the risk of tumor formation from hPSC-derived CTPs. Among currently available assays, a highly efficient culture (HEC) assay is reported to be one of the most sensitive for the detection of residual undifferentiated hPSCs.METHODS:
MEASURE first validated the detection sensitivity of HEC assay and then investigated the feasibility of magnetic-activated cell sorting (MACS) to improve sensitivity.RESULTS:
The multisite experiments confirmed that the lower limit of detection under various conditions to which the human induced pluripotent stem cell lines and culture medium/substrate were subjected was 0.001%. In addition, MACS concentrated cells expressing undifferentiated cell markers and consequently achieved a detection sensitivity of 0.00002%.CONCLUSIONS:
These results indicate that HEC assay is highly sensitive and robust and that the application of MACS on this assay is a promising tool for further mitigation of the potential tumorigenicity risk of hPSC-derived CTPs.Palabras clave
Texto completo:
1
Base de datos:
MEDLINE
Asunto principal:
Técnicas de Cultivo de Célula
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Células Madre Pluripotentes
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Células Madre Pluripotentes Inducidas
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Tratamiento Basado en Trasplante de Células y Tejidos
Tipo de estudio:
Clinical_trials
/
Diagnostic_studies
Idioma:
En
Revista:
Cytotherapy
Asunto de la revista:
TERAPEUTICA
Año:
2021
Tipo del documento:
Article