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薬事法に基づき自己培養骨髄間葉系幹細胞を医薬品(細胞生物製剤)として実用化するべく,医師主導治験を実施している。これまで,前臨床試験(GLP試験)を完了し,GMP(good manufacturing practice)で細胞製剤(治験薬)を製造し,2013年3月より医師主導治験(第III相,二重盲検無作為化試験,検証的試験)を医薬品承認審査調和国際会議のgood clinical practice基準に基づいて実施中である。本稿では認知機能向上の可能性について言及する。
Abstract
Intravenously administrated mesenchymal stem cells (MSCs) isolated and expanded from human bone marrow have been reported to ameliorate functional deficits in several CNS diseases in both experimental animal models and clinics. Therapeutic mechanisms may include replacement of damaged cells, neuroprotective effects, induction of axonal sprouting, and neovascularization. Here, we review the reparative and protective properties of transplanted MSCs in stroke, describe initial clinical studies on intravenous MSC delivery in stroke patients, and discuss a perspective on the prospects of MSCs for dementia.
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