| Project/Area Number |
17209042
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| Research Category |
Grant-in-Aid for Scientific Research (A)
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| Allocation Type | Single-year Grants |
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| Section | 一般 |
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| Research Field |
General surgery
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| Research Institution | The University of Tokyo |
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Principal Investigator |
TAHARA Hideaki The University of Tokyo, Institute of Medical Science, Professor (70322071)
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| Co-Investigator(Kenkyū-buntansha) |
佐々木 勝則 東京大学, 医科学研究所, 特任准教授 (60336394)
角田 卓也 東京大学, 医科学研究所, 産学官連携研究員(特任助教授) (30275359)
高山 卓也 東京大学, 医科学研究所, 講師 (10332579)
北村 義浩 東京大学, 医科学研究所, 助教授 (10202037)
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| Project Period (FY) |
2005 – 2007
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| Project Status |
Completed (Fiscal Year 2007)
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| Budget Amount *help |
¥47,580,000 (Direct Cost: ¥36,600,000、Indirect Cost: ¥10,980,000)
Fiscal Year 2007: ¥15,340,000 (Direct Cost: ¥11,800,000、Indirect Cost: ¥3,540,000)
Fiscal Year 2006: ¥15,340,000 (Direct Cost: ¥11,800,000、Indirect Cost: ¥3,540,000)
Fiscal Year 2005: ¥16,900,000 (Direct Cost: ¥13,000,000、Indirect Cost: ¥3,900,000)
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| Keywords | gene Therapy / tumor immunology / adenoviral vector / Inteleukin-12 / GMP / translational research / dendritic cells / RCA |
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| Research Abstract |
The final goal of this project is to establish a system in Japanese academia to support early-phase clinical studies of gene therapy. In order to achieve it, we initiated a process to manufacture adenoviral vector carrying Interleukin-12 (Ad-IL-12) to be used in cancer immuno-gene therapy protocol using dendritic cells (DCs) transduced with IL-12 genes. To facilitate this project, we started, using our unique facility called "Core Facility for Therapeutic Vectors (CFTV)", making our own master cell bank (MCB) and working cell bank (WCB) of producer cells (293 cells) which have qualities required by the Food and Drug Administration (FDA) of the United States. We have carried on our project as initially proposed and successfully established MCB and WCB which are certified as FDA recommended. At the same time, we constructed cosmid DNA which would be used to make Ad-IL-12. We also made Standard Operating Procedures (SOPs) to ensure the quality of the final products. Furthermore, we also studied on the function and manipulation of DCs which are the target of the gene-transduction and the vehicle to be used in our clinical trial, and revealed important information related to the clinical trial. These results suggest that we are now have a viable system which could support gene therapy clinical protocols in Japan.
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