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Pre-Clinical Toxicity Evaluation Accompanied with Biodistribution of Mixed Activated Killer Immune Cells
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Manman ZHAO1, Lijun JIANG2, Chao WANG1, Guitao HUO1, Hua JIANG1, Liang BEN2, Chao LI2, Tiantian HOU1, Sanlong WANG1, Xingchao GENG1, Xiaobing ZHOU1, *
Chinese Pharmaceutical Journal | 2024, 59(20) : 1881 - 1888
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Chinese Pharmaceutical Journal | 2024, 59(20): 1881-1888
Pre-Clinical Toxicity Evaluation Accompanied with Biodistribution of Mixed Activated Killer Immune Cells
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Manman ZHAO1, Lijun JIANG2, Chao WANG1, Guitao HUO1, Hua JIANG1, Liang BEN2, Chao LI2, Tiantian HOU1, Sanlong WANG1, Xingchao GENG1, Xiaobing ZHOU1, *
Affiliations
  • 1 Key Laboratory of Beijing for Nonclinical Safety Evaluation Research of Drugs, Institute for Safety Evaluation, National Institutes for Food and Drug Control, Beijing 100176, China
  • 2 Tuohua Bio-technology Co., Ltd., Siping 136001, China
Published: 2024-10-22 doi: 10.11669/cpj.2024.20.001
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OBJECTIVE To evaluate the safety and biodistribution characteristics of mixed activated killer (MAK) immune cells derived from the blood of tumor patients in immunodeficient mice. METHODS Immunodeficient NOG mice were injected with MAK cells 9 times via the tail vein. The mice were observed continuously for 28 d after the last administration. The clinical symptoms, body weight, food intake, hematological and serum biochemical indexes, cytokine indexes and histopathological changes in mice were investigated. In the meanwhile, the distribution characteristics of MAK cells in peripheral blood and various tissues and organs were investigated. RESULTS MAK cells had no significant effect on clinical symptoms, the injection site, body weight and food intake in mice, and could increase the level of human interferon gamma in serum of mice. MAK cells could elevate lymphocytes%, monocytes%, white blood cells and decrease basophils% in peripheral blood. Mix cell aggregates were observed in most organs. Massive expansion of MAK cells was observed in most tissues of mice after administration of MAK cells for 28 d. CONCLUSION MAK cells could proliferate and induce immune responses in immunodeficient NOG mice without obvious toxic reactions. Given the above, the data of this study can provide a reference for the non-clinical safety evaluation of related products.

mixed activated killer (MAK) immune cell  /  immunodeficient mice  /  toxicity evaluation  /  biodistribution
Manman ZHAO, Lijun JIANG, Chao WANG, Guitao HUO, Hua JIANG, Liang BEN, Chao LI, Tiantian HOU, Sanlong WANG, Xingchao GENG, Xiaobing ZHOU. Pre-Clinical Toxicity Evaluation Accompanied with Biodistribution of Mixed Activated Killer Immune Cells[J]. Chinese Pharmaceutical Journal, 2024 , 59 (20) : 1881 -1888 . DOI: 10.11669/cpj.2024.20.001
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Year 2024 volume 59 Issue 20
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doi: 10.11669/cpj.2024.20.001
  • Receive Date：2024-06-25
  • Online Date：2025-12-30
  • Published：2024-10-22
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  • Received：2024-06-25
Funding
Affiliations
    1 Key Laboratory of Beijing for Nonclinical Safety Evaluation Research of Drugs, Institute for Safety Evaluation, National Institutes for Food and Drug Control, Beijing 100176, China
    2 Tuohua Bio-technology Co., Ltd., Siping 136001, China
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https://castjournals.cast.org.cn/joweb/zgyxzz/EN/10.11669/cpj.2024.20.001
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表12种不同金属材料的力学参数
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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