[HTML][HTML] Tumorigenicity assessment of cell therapy products: The need for global consensus and points to consider
Y Sato, H Bando, M Di Piazza, G Gowing, C Herberts… - Cytotherapy, 2019 - Elsevier
Pluripotent stem cells offer the potential for an unlimited source for cell therapy products.
However, there is concern regarding the tumorigenicity of these products in humans, mainly
due to the possible unintended contamination of undifferentiated cells or transformed cells.
Because of the complex nature of these new therapies and the lack of a globally accepted
consensus on the strategy for tumorigenicity evaluation, a case-by-case approach is
recommended for the risk assessment of each cell therapy product. In general, therapeutic …
However, there is concern regarding the tumorigenicity of these products in humans, mainly
due to the possible unintended contamination of undifferentiated cells or transformed cells.
Because of the complex nature of these new therapies and the lack of a globally accepted
consensus on the strategy for tumorigenicity evaluation, a case-by-case approach is
recommended for the risk assessment of each cell therapy product. In general, therapeutic …