Recently gene therapy is raising up as a new strategy of cancer treatment. Many kinds of strategy for gene therapy of cancer were reported. HSV-TK gene, wild-type p53 gene, HLA gene and cytokine genes such as IL-2, IL-4, IL-7, TNF, IFN, GM-CSF etc. are used in gene therapy experiments and trials. However, many kind of problems still exist. Final end point of gene therapy of cancer is the repair of altered genes in cancer cells. However, technology of repair for altered genes in cancer cells is still not available. In the most of on going gene therapy experiments and trials, cancer cells are treated by gene or gene modified cells via immune systems or other unknown bystander effects. The transfection of gene dramatically change the phenotype of cancer cells, especially the growth pattern
in vivo. On the other hand, therapeutic effects of gene or gene modified cells via immune systems or other unknown bystander effects on cancer cells without gene modification are not satisfied. Thus, the development of not only efficient vector systems but also new strategy using new genes are essential for the further application of gene therapy to clinical trials. Clinical trials of gene therapy have been started in USA, France, Italy, UK, Netherlands and China. In Japan, guide-lines for clinical trials of gene therapy were established from Ministry of Health and Welfare and Ministry of Education. However, no-body know when it could be started in Japan. Vectors supply and safety check and establishment of social consensus are critical for the introduction of gene therapy trials in Japan.
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