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

实体瘤基因治疗载体注射装置的研制及临床应用

基本信息

批准号：
13557134
负责人：
NASU Yasutomo
金额：
$ 6.34万
依托单位：
Okayama University
依托单位国家：
日本
项目类别：
Grant-in-Aid for Scientific Research (B)
财政年份：
2001
资助国家：
日本
起止时间：
2001 至 2002
项目状态：
已结题

来源：
https://kaken.nii.ac.jp/en/grant/KAKENHI-PROJECT-13557134/
关键词：
gene therapy solid tumor prostate cancer

项目摘要

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.

我们发明了一种新的装置，用于实体瘤基因治疗的载体注射，并申请了专利。在本研究中，我们实际建造了这台机器，并初步检查其安全性，条件和调整的最佳条件，实际注射。本研究以前列腺为靶器官。1）游离肉块最佳注射条件实验通过将染料注射到游离肉块中，分析了最佳注射条件。结果表明，注射速度以0.1ml/s为最佳。2）装置的改进对于每个部分的改进，重复进行模拟。主要改进是形成脚踏开关，以便操作员可以在眼睛保持在超声屏幕上的情况下操作器械。我们使注射速度和体积可变，以便我们可以根据肿瘤体积改变注射条件。3）对患者的实际注射我们有一个前列腺癌基因治疗方案，用于激素治疗后局部复发而无转移证据的患者。该方案得到了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）的复制缺陷型腺病毒（ADV）直接注射到前列腺中，随后静脉内施用前药更昔洛韦（GCV）14天。7例患者使用该装置进行注射，注射精确且一致。结论：该装置是一种可靠的载体注射装置，适用于其他癌症。