Project/Area Number |
18K12137
|
Research Category |
Grant-in-Aid for Scientific Research (C)
|
Allocation Type | Multi-year Fund |
Section | 一般 |
Review Section |
Basic Section 90140:Medical technology assessment-related
|
Research Institution | National Institute of Health Sciences |
Principal Investigator |
KUSAKAWA Shinji 国立医薬品食品衛生研究所, 再生・細胞医療製品部, 主任研究官 (80462802)
|
Project Period (FY) |
2018-04-01 – 2021-03-31
|
Project Status |
Completed (Fiscal Year 2020)
|
Budget Amount *help |
¥4,290,000 (Direct Cost: ¥3,300,000、Indirect Cost: ¥990,000)
Fiscal Year 2020: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Fiscal Year 2019: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2018: ¥1,820,000 (Direct Cost: ¥1,400,000、Indirect Cost: ¥420,000)
|
Keywords | 三次元培養 / 造腫瘍性試験 / 細胞加工製品 / 再生医療等製品 / 形質転換細胞 / 三次元細胞培養 / 悪性形質転換細胞 / 間葉系幹細胞 / 造腫瘍性 |
Outline of Final Research Achievements |
Cells cultured in a medium containing a novel polymer LA717 derived from natural products and in a low-adhesion culture vessel are uniformly dispersed in a three-dimensional environment. When normal cells and tumorigenic cells (transformed cells) were co-cultured in this three-dimensional environment, it was revealed that the dispersed normal cells did not proliferate due to the lack of a scaffold, whereas tumorigenic cells with anchorage-independent growth ability divided, increased, and formed colonies from single cells with a specific frequency within a specified period. By fluorescently labeling these colonies, it became possible to detect them efficiently by image analysis. Applying the novel three-dimensional culture method, a new in vitro test method was established to evaluate the contamination of human cell-based therapeutic products with transformed cells as cellular impurities.
|
Academic Significance and Societal Importance of the Research Achievements |
本研究課題で検討された新しい三次元細胞培養法は、市販のポリマー試薬をごく少量添加した培地と低接着性培養容器を用いるだけのシンプルなものである。当該培養法は、寒天培地等を用いる方法と比較して、非常に簡便な操作で三次元培養環境を構築し、細胞の足場非依存的増殖能の効率的な評価が可能であることが明らかとなった。 新規三次元培養法を応用した、ヒト細胞加工製品中の形質転換細胞の混在を評価するための新たなin vitro試験法は、再生医療等製品の品質評価に有用な試験と考えられ、製品開発を後押しするものとして実用化が期待できる。
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