| Project/Area Number |
16K08382
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Research Field |
Medical pharmacy
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| Research Institution | Meiji Pharmaceutical University |
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Principal Investigator |
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| Co-Investigator(Kenkyū-buntansha) |
松井 勝彦 明治薬科大学, 薬学部, 教授 (20257140)
佐藤 陽治 国立医薬品食品衛生研究所, 再生・細胞医療製品部, 部長 (40312285)
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| Project Period (FY) |
2016-04-01 – 2019-03-31
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| Project Status |
Completed (Fiscal Year 2018)
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| Budget Amount *help |
¥4,940,000 (Direct Cost: ¥3,800,000、Indirect Cost: ¥1,140,000)
Fiscal Year 2018: ¥390,000 (Direct Cost: ¥300,000、Indirect Cost: ¥90,000)
Fiscal Year 2017: ¥1,820,000 (Direct Cost: ¥1,400,000、Indirect Cost: ¥420,000)
Fiscal Year 2016: ¥2,730,000 (Direct Cost: ¥2,100,000、Indirect Cost: ¥630,000)
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| Keywords | 再生医療 / 医薬品安全性 / 幹細胞 / 細胞分化 / バリデーション / 間葉系幹細胞 / 血管内皮増殖因子 / 血管新生 / 細胞組織製品 / 安全性保証 / 細胞・組織加工製品 / 細胞バリデーション |
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| Outline of Final Research Achievements |
Observation of cardiomyocyte differentiation from stem cells revealed that the cells became confluent about 4 days after differentiation induction treatment, and that small autonomously beating nodes were evident by 10 days. The timing of the appearance of autonomously beating nodes and their number differed among cell lines and sublines. Secretion of vascular endothelial growth factor by human mesenchymal stem cells under ischemic conditions varied among the stem cell line lot numbers. As this difference in secretory capacity may affect the degree of angiogenesis and therapeutic efficacy after stem cell transplantation, and we explored factors that might predict the repair capacity of cells. In addition, analysis of the immunological behavior of mesenchymal stem cells revealed no immune effect on them. As it will be important to develop a highly accurate assay method for detection of abnormal cells, the safety of cell and tissue processing products was also investigated.
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| Academic Significance and Societal Importance of the Research Achievements |
難治性疾患の次世代の治療に幹細胞由来細胞治療薬の臨床応用が進んでいる。細胞組織製品を使用する際には品質を評価するための細胞特性解析指標やそれら指標による規格の設定がレギュラトリーの面からも重要になる。本研究を遂行ことで、幹細胞の諸機能と緊密に関連する因子を特定し、それらの臨床応用への有用性を証明することで、再生医療における幹細胞の品質管理法の確立や安全性確保の基盤形成が達成される。また、それらの生体における生理的役割と細胞機能との因果関係が明らかになることで、幹細胞の様々な機能に関する知見が統合され、自然界における幹細胞の真の役割の全体像を明らかにし、再生医療への進歩に貢献することとなる。
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