QUALITY ASSESSMENT AND ASSURANCE OF TEMCELL<sup>TM</sup>, A CELLULAR THERAPY PRODUCT

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  • Sugiyama Hiroki
    Department of Transfusion Medicine and Cellular Therapy, Hyogo College of Medicine
  • Ikemoto Junko
    Department of Transfusion Medicine and Cellular Therapy, Hyogo College of Medicine
  • Yoshihara Satoshi
    Department of Transfusion Medicine and Cellular Therapy, Hyogo College of Medicine Division of Hematology, Department of Internal Medicine, Hyogo College of Medicine
  • Yamamoto Nao
    Department of Transfusion Medicine and Cellular Therapy, Hyogo College of Medicine
  • Ohno Mayuko
    Department of Transfusion Medicine and Cellular Therapy, Hyogo College of Medicine
  • Harada Yuki
    Department of Transfusion Medicine and Cellular Therapy, Hyogo College of Medicine
  • Otsuka Shinya
    Department of Transfusion Medicine and Cellular Therapy, Hyogo College of Medicine
  • Onomoto Hitomi
    Department of Transfusion Medicine and Cellular Therapy, Hyogo College of Medicine
  • Murata Rie
    Department of Transfusion Medicine and Cellular Therapy, Hyogo College of Medicine
  • Maeda Kazuhiro
    Department of Transfusion Medicine and Cellular Therapy, Hyogo College of Medicine
  • Okuda Noriko
    Department of Transfusion Medicine and Cellular Therapy, Hyogo College of Medicine
  • Yoshihara Kyoko
    Department of Transfusion Medicine and Cellular Therapy, Hyogo College of Medicine Division of Hematology, Department of Internal Medicine, Hyogo College of Medicine
  • Yamahara Kenichi
    Department of Transfusion Medicine and Cellular Therapy, Hyogo College of Medicine Division of Hematology, Department of Internal Medicine, Hyogo College of Medicine
  • Okada Masaya
    Division of Hematology, Department of Internal Medicine, Hyogo College of Medicine
  • Fujimori Yoshihiro
    Department of Transfusion Medicine and Cellular Therapy, Hyogo College of Medicine Division of Hematology, Department of Internal Medicine, Hyogo College of Medicine

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Other Title
  • 細胞治療製剤（テムセルHS注<sup>Ⓡ</sup>）の生細胞率測定による品質評価

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<p>テムセルHS注Ⓡ（以下，テムセル）は，健康成人骨髄液から得られたヒト間葉系幹細胞を拡大培養し製造された再生医療等製品であり，造血幹細胞移植後の治療抵抗性急性移植片対宿主病を適応として2016年に臨床導入された．当院におけるテムセル解凍，調製後の生細胞率につき，35症例に投与された計564バッグを対象に後方視的解析を行った．初期の1ロット（2バッグ）において生細胞率が63%，68%と著しく低値であり，解凍時の手順の変更を行った．これを除くと生細胞率は平均値95%±1.7％であり，全バッグにおいて当初投与基準として示されていた70％を超えていた．また，保管や細胞プロセシング（解凍・調製）の過程において生じうる同一ロット内のバッグ間における生細胞率の格差は最大で11％にとどまっていた．生細胞率の測定は，細胞治療製剤の品質評価・品質保証の一助となると同時に，輸血部門における細胞の解凍，調製手順の妥当性を検証するために有用であると考えられる．</p>

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