Preliminary evaluation of safety of conditionally replication adenovirus M4
Preliminary evaluation of safety of conditionally replication adenovirus M4
复制标题
条件复制腺病毒M4安全性初步评价
DOI：
10.1007/s11596-012-1054-y
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发表时间：
2012
期刊：
影响因子：
--
通讯作者：
Gao Q
中科院分区：
文献类型：
--
作者：
Chen C;Fang H;Rao Y;Wu P;He Y;Ma D;Gao Q
本实验室构建的条件复制腺病毒M4具有良好的抗肿瘤、抗转移作用，具有良好的临床应用前景。然而，M4临床应用面临诸多问题。最重要的因素之一是M4的安全性。在本研究中，我们通过与Adv-TK进行比较来考察M4的安全性，Adv-TK在I-III期临床试验中被证明是安全的。 M4和Adv-TK分别经尾静脉注射至小鼠体内，并在指定时间处死小鼠。收集血液进行生化测试，收获肝脏进行苏木精和伊红（H&E）染色和病毒定量，并分离脾淋巴细胞进行腺病毒特异性细胞免疫反应。我们的结果表明M4对小鼠一般症状没有明显影响。仅在M4组中观察到集合菌中炎症细胞的短暂可逆性浸润，并且在注射M4和Adv-TK后均检测到Cr水平短暂性轻微升高。 M4诱导的腺病毒特异性细胞免疫反应与Adv-TK相似，M4在小鼠肝脏中的分布和代谢也与Adv-TK相似。结论是条件复制腺病毒M4与Adv-TK具有相同的安全性。该研究为M4即将开展的临床试验提供安全性依据。
Conditionally replication adenovirus M4, which was constructed in our lab, was proved to have good clinical application prospect for its good anti-tumor and anti-metastasis effect. However, clinically applying M4 faces many problems. One of the most important is the safety of M4. In this study, we investigated the safety of M4 by comparing with Adv-TK, which was proved to be safe in I–III phase clinical trials. M4 and Adv-TK were injected into mice via the tail vein separately, and the mice were sacrificed at the indicated time. Blood was collected for biochemical tests, the liver was harvested for hematoxylin and eosin (H&E) staining and viral quantification, and splenic lymphocytes were separated for adenovirus specific cellular immune response. Our results showed that M4 had no obvious effect on mouse general symptoms. A transient reversible infiltration of inflammatory cells in collect abbacy was only observed in M4 group, and a transient slight increase in Cr level was detected both after M4 and Adv-TK injection. The adenovirus specific cellular immune response induced by M4 was similar to that by Adv-TK, and the distribution and metabolism of M4 in the mouse liver were also similar to those of Adv-TK. It was concluded that conditionally replication adenovirus M4 had the same safety as Adv-TK. The study provides safety basis for the coming clinical trials of M4.
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影响因子：
6.2
作者：
Rosen, Daniel G.;Mercado-Uribe, Imelda;Liu, Jinsong
通讯作者：
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20.3
作者：
Santos, Fabio P. S.;Kantarjian, Hagop M.;Verstovsek, Srdan
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Verstovsek, Srdan
影响因子：
11.2
作者：
S. Freytag;H. Stricker;J. Pegg;D. Paielli;D. Pradhan;J. Peabody;M. Deperalta-Venturina;X. Xia;S. Brown;Mei Lu;J. H. Kim
通讯作者：
S. Freytag;H. Stricker;J. Pegg;D. Paielli;D. Pradhan;J. Peabody;M. Deperalta-Venturina;X. Xia;S. Brown;Mei Lu;J. H. Kim
影响因子：
4.2
作者：
D. Curiel
通讯作者：
D. Curiel