指定 against K.K. Heriosu
Action summary
- Company
- K.K. HeriosuRomanizedOriginal: 株式会社ヘリオス
- Governing law
- 薬事法薬事法
- Action type
- 指定指定
- Action date
- February 28, 2017
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
A stem cell product used for the treatment of acute cerebral infarction, derived from adult human (same species) bone marrow multipotent progenitor cells, developed overseas. It is a suspension of adherent stem cells collected and processed from donor bone marrow, with novelty and high breakthrough potential aimed at improving functional impairments caused by acute cerebral infarction.
Show original Japanese text
ヒト（同種）成人骨髄由来多能性前駆細胞を用いた急性期脳梗塞の治療を目的とした幹細胞製品であり、海外で開発されている。ドナーの骨髄から採取・加工した接着性幹細胞の懸濁液であり、急性期の脳梗塞に伴う機能障害の改善を目的とする点に新規性があり、画期性が高い。
Source
Original Ministry of Health, Labour and Welfare announcement (in Japanese)The original Japanese disclosure is the authoritative record.
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Language
日本語版を見る (Japanese)About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.