Adenoviral-mediated gene transfer of vascular endothelial growth factor in critical limb ischemia: safety results from a phase I trial
Adenoviral-mediated gene transfer of vascular endothelial growth factor in critical limb ischemia: safety results from a phase I trial
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腺病毒介导的血管内皮生长因子基因转移治疗严重肢体缺血：I 期试验的安全性结果
作者：
E. Mohler;S. Rajagopalan;J. Olin;J. Trachtenberg;H. Rasmussen;R. Pak;R. Crystal
严重肢体缺血（CLI）的典型特征是继发于晚期外周动脉疾病（PAD）的休息疼痛和/或组织坏死，其特征是休息时肢体预融合减少。作为I期试验的一部分，我们在CLI患者中测试了CI-1023 （AdGV VEGF121.10）血管生成策略的安全性，CI-1023是一种复制缺陷腺病毒，编码人血管内皮生长因子亚型121。15名年龄在50至35岁之间的CLI患者和涉及腹股沟下血管的血管造影疾病患者接受了肌内注射CI-1023（4 3 108至4 3 1010颗粒单位，n = 13）或安慰剂（n = 2）。所有患者对注射的耐受性良好，没有发生与手术相关的严重并发症。一名患者出现短暂性水肿。在一年的治疗过程中，总共报告了79例不良事件。CI-1023组发生1例死亡（第136天）和1例恶性肿瘤（第332天）。CI-1023对于因PAD引起的严重肢体缺血患者单次给药耐受性良好且安全。需要进一步的研究来确定这种治疗性血管生成的有效性。
Critical limb ischemia (CLI) is typifi ed by rest pain and/or tissue necrosis secondary to advanced peripheral arterial disease (PAD) and is characterized by diminution in limb per-fusion at rest. We tested the safety of an angiogenic strategy with CI-1023 (AdGV VEGF121.10), a replication-defi cient adenovirus encoding human vascular endothelial growth factor isoform 121 in patients with CLI as part of a phase I trial. Fifteen subjects >35 years of age with CLI and angiographic disease involving the infra-inguinal vessels underwent intramuscular injection of CI-1023 (4 3 108 to 4 3 1010 particle units, n = 13) or placebo (n = 2). All of the patients tolerated the injection well and there were no serious complications related to the procedure. Transient edema was noted in one patient. A total of 79 adverse events were reported over the course of one year. One death (day 136) and one malignancy (day 332) occurred in the CI-1023 group. CI-1023 appears to be well tolerated and safe for single-dose administration in patients with critical limb ischemia due to PAD. Further studies are needed to determine the efficacy of this form of therapeutic angiogenesis.
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通过在线超声成像研究人体肌肉内基因转移的体内分析。
影响因子：
4.2
作者：
Rauh,G;Pieczek,A;Irwin,W;Schainfeld,R;Isner,JM
通讯作者：
Isner,JM
影响因子：
4.2
作者：
Harvey, BG;Maroni, J;Crystal, RG
通讯作者：
Crystal, RG
影响因子：
37.8
作者：
Baumgartner, I;Pieczek, A;Isner, JM
通讯作者：
Isner, JM
缺血性兔后肢 VEGF 诱导血管分布增强的生理学评估。
DOI：
10.1152/ajpheart.1994.267.4.h1263
发表时间：
1994
期刊：
The American journal of physiology
影响因子：
--
作者：
Bauters,C;Asahara,T;Zheng,LP;Takeshita,S;Bunting,S;Ferrara,N;Symes,JF;Isner,JM
通讯作者：
Isner,JM