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Gene therapy for peripheral arterial disease

机译：外周动脉疾病的基因治疗

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Introduction: Gene therapy has emerged as a novel therapy to promote angiogenesis in patients with critical limb ischemia (CLI) caused by peripheral artery disease. Researchers working in this area have focused on pro-angiogenic factors, such as VEGF, fibroblast growth factor (FGF) and hepatocyte growth factor (HGF). Based on the elaborate studies and favorable results of basic research using naked plasmid DNA (pDNA) encoding these growth factors, some clinical Phase I and Phase II trials have been performed. The results of these studies demonstrate the safety of these approaches and their potential for symptomatic improvement in CLI patients. However, the Phase III clinical trials have so far been limited to HGF gene therapy. Because one pitfall of the Phase III trials has been the limited transgene expression achieved using naked pDNA alone, the development of more efficient gene transfer systems, such as ultrasound microbubbles and the needleless injector, as well as the addition of other genes will make these novel therapies more effective and ease the symptoms of CLI.Areas covered: This study reviews the previously published basic research and clinical trials that have studied VEGF, FGF and HGF gene therapies for the treatment of CLI. Adjunctive therapies, such as the addition of prostacyclin synthase genes and the development of more efficient gene transfer techniques for pDNA, are also reviewed.Expert opinion: To date, clinical studies have demonstrated the safety of gene therapy in limb ischemia but the effectiveness of this treatment has not been determined. Larger clinical studies, as well as the development of more effective gene therapy, are needed to achieve and confirm beneficial effects.
机译：简介：基因疗法已成为一种新型疗法，可促进由外周动脉疾病引起的严重肢体缺血（CLI）患者的血管生成。该领域的研究人员致力于促血管生成因子，例如VEGF，成纤维细胞生长因子（FGF）和肝细胞生长因子（HGF）。基于详尽的研究以及使用编码这些生长因子的裸质粒DNA（pDNA）进行的基础研究的良好结果，已进行了一些临床的I期和II期临床试验。这些研究的结果证明了这些方法的安全性及其在CLI患者中症状改善的潜力。但是，到目前为止，III期临床试验仅限于HGF基因治疗。由于III期试验的一个陷阱是仅使用裸露的pDNA只能实现有限的转基因表达，因此开发更有效的基因转移系统（例如超声微泡和无针注射器）以及添加其他基因将使这些新技术成为现实。覆盖的区域：本研究回顾了先前发表的基础研究和临床试验，这些研究已经研究了用于治疗CLI的VEGF，FGF和HGF基因疗法。还回顾了辅助疗法，例如添加前列环素合酶基因和开发更有效的pDNA基因转移技术。专家意见：迄今为止，临床研究已证明基因疗法在肢体缺血中的安全性，但这种方法的有效性治疗方法尚未确定。为了获得并确认有益的效果，需要进行更大的临床研究以及开发更有效的基因疗法。

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