学術情報：国内の企業・大学の取り組み、背景論文
国内で企業・大学による治験進行中の間葉系幹細胞（MSC）等の治療対象
2018.9 NIKKEZI MEDICALより引用
脳梗塞
ヘリオス：他家骨髄由来多能性前駆細胞を点滴静注
ニプロ：自家間葉系幹細胞を培養し点滴静注
脊髄損傷
ニプロ：自家間葉系幹細胞を培養し点滴静注
2019年2月20日の中央社会保険医療協議会総会で、ニプロの脊髄損傷治療用自己骨髄間葉系幹細胞「ステミラック注」の薬価収載が決定しています。同治療薬は、再生医療等製品版・先駆け審査指定制度の対象製品として初めて、2018年12月に条件・期限付きで承認されたものです。
以下関連情報
https://medical.nikkeibp.co.jp/leaf/mem/pub/report/201902/559944.html
急性心筋梗塞
生命科学インスティチュート：他家Muse細胞を静注
肝硬変
ロート製薬：他家脂肪由来幹細胞を培養し投与
外傷性軟骨及び李男性骨軟骨炎
ツーセル、中外製薬：他家滑膜間葉系幹細胞を培養し移植
半月板損傷
東京医科歯科大学：自家滑膜幹細胞を培養し移植
腹圧性尿失禁
名古屋大学：自家脂肪由来幹細胞を移植
脂肪由来間葉系幹細胞投与の安全性
- ・教科書や学術雑誌上で、間葉系幹細胞の点滴投与・局所投与に関する基礎論文、臨床論文は多数存在し、企業・大学による臨床研究多数進行中です。
- ・当該治療を国内において多くの医療機関が既に提供しており、当該治療に直接起因する重篤な有害事象の報告はありません。
- ・「幹細胞は免疫寛容作用があるので一部では他家移植すら実施されているが特に問題が起こってない点」も考慮すれば、今回の治療は全て自家細胞移植であり、安全性はより大きいと考えられます。
- ・当医療機関で実施するASCの培養法については株式会社バイオ未来工房より技術継承しています。同社は既に前述の国内でMSCを点滴ないしは注射投与による治療を実施している複数の医療機関に同様の細胞培養法の技術継承をし、各医療機関はそれに基づき培養したASCを安全に投与しています。
当クリニックにおいても同様の手法でASC投与を実施するため治療の安全性は担保されます。
背景論文
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