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Outline
Cell therapy products (CTPs) have the potential of tumor formation risks, i.e., tumorigenicity, oncogenicity and tumor-enhancement. Since the final stem cell therapy products derived from human embryonic stem cells and human induced pluripotent stem cells may contain undifferentiated hPSCs, malignant transformed cells/mutations and genetic instability, they have the highest risk of tumorigenicity. Tumorigenicity and oncogenicity risk of CTPs may be largely increased in genetically modified stem cells, that express foreign genes (such as various growth factors), as well as the oncogene activated by insertion mutations of genetically modified viral vectors (such as retroviruses and lentiviruses). While terminally differentiated somatic cell products have lower risk of tumorigenicity. During recent years, increasing number of cell therapy products have entered the clinical application, the tumor formation risk of which is a safety issue that is concerned by product developers and regulatory authorities. This article introduces the concepts of tumorigenicity, oncogenicity and tumor-enhancement of CTPs, providing a comprehensive overview of the current evaluation methods in vitro and in vivo, as well as the general considerations for risk assessment of tumorigenicity and oncogenicity of CTPs.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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