DEVELOPMENT AND CLINICAL APPLICATION OF VECTOR INJECTION DEVICE FOR GENE THERAPY OF SOLID TUMOR

我们创新了一种用于实体瘤基因治疗的载体注射装置，并申请了专利。在本研究中，我们实际建造了这台机器，并对其安全性、状况进行了初步检查，并调整了实际注射的最佳条件。本实验以前列腺靶器官1)游离肉块实验确定最佳注射条件通过将染料注入游离肉块，分析最佳注射条件。因此，0.1ml/s的注射速度被认为是最佳的。2)装置的改进为了改进各部分，重复进行模拟。主要的改进是形成了脚踏开关，这样操作员就可以操作设备，同时眼睛保持在超声波屏幕上。我们通过改变注射速度和注射体积来改变注射条件，从而可以根据肿瘤的体积改变注射条件。3)对患者进行实际注射我们有一种前列腺癌基因治疗方案，用于激素治疗后局部复发但没有转移证据的患者。该协议得到了IRE和政府的批准。在超声引导下，将含有单纯疱疹病毒胸苷激酶基因(HSV-tk)的复制缺陷腺病毒(ADV)直接注射到前列腺内，然后静脉注射前药更昔洛韦(GCV)，连续14天。使用该装置对7例患者进行了注射，注射操作准确、一致。结论：该装置是一种可靠、实用的载体注射装置，适用于其他肿瘤的治疗。

We have innovated a new device, for vector injection for gene therapy of solid tumor and applied for patent. In this study we actually constructed this machine and preliminary checked its safety, condition and adjusted optimal condition for actual injection. In our series prostate was regarded as a target organ.1)Experiment using free meat block to determine optimal injection conditionBy injecting a dye into free meat block, optimal condition of injection was analyzed. As a result, injection speed at 0.1ml/second was thought to be optimal.2)Improvement of the deviceFor the improvement of the each part, a simulation was repeated. Major improvement is a formation of foot switch so as the operator can handle the device with his eye kept of the ultrasound screen. We made injection on speed and volume changeable so as we can change the injection condition depending on the tumor volume.3)Actual injection to the patinetsWe have a prostate cancer gene therapy protocol for the patients of local recurrence after hormonal therapy without evidence of metastasis. This protocol is approved by IRE and government. A replication-deficient adenovirus (ADV) containing the herpes simplex virus thymidine kinase gene (HSV-tk) is injected directly into the prostate under ultrasound guidance, followed by intravenous administration of the prodrug ganciclovir (GCV) for 14 days.. Seven cases were injected using this device and injections wete performed precisely and consistently. It is concluded that this device is reliable and useful for vector injection and applicable for the other cancer.