Efficacy and Safety of Clinical-Grade Human Vascular Endothelial Growth Factor-DΔNΔC Gene Therapy Containing Residual Replication-Competent Adenoviruses
Efficacy and Safety of Clinical-Grade Human Vascular Endothelial Growth Factor-DΔNΔC Gene Therapy Containing Residual Replication-Competent Adenoviruses
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DOI：
10.1089/hum.2020.299
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发表时间：
2021-03-04
影响因子：
4.2
通讯作者：
Yla-Herttuala, Seppo
中科院分区：
文献类型：
--
作者：
Leikas, Aleksi J.;Laham-Karam, Nihay;Yla-Herttuala, Seppo
血管内皮生长因子D（VEGF-D）基因治疗（GT）诱导血管新生的生物旁路是治疗心肌缺血的新概念。血清5型腺病毒用于临床试验，用于将VEGF-D cDNA转移到缺血心肌中。然而，在腺病毒产品中存在可复制载体是一个广泛认识到的问题，可能对治疗的患者造成潜在的安全风险。我们比较了三个不同的VEGF-D GT生产批次，其中含有不同水平的复制能力腺病毒（RCA），在3 x 10（10）个病毒颗粒（vp）中进行了测试：
Biological bypass through induced angiogenesis by vascular endothelial growth factor D (VEGF-D) gene therapy (GT) is a new concept for the treatment of cardiac ischemia. Serotype 5 adenoviruses are used in the clinical trials for transferring the VEGF-D cDNA into the ischemic myocardium. However, the presence of replication-competent vectors in the adenovirus products is a widely recognized problem that may pose a potential safety risk to the treated patients. We compared three different VEGF-D GT production lots containing different levels of replication-competent adenoviruses (RCA) tested in 3 x 10(10) viral particles (vp):