指定 against K.K. Serusido
Action summary
- Company
- K.K. SerusidoRomanizedOriginal: 株式会社セルシード
- 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
The product is a cell sheet cultured from the patient's own oral mucosal epithelial cells, intended to prevent stenosis and shorten the time to re-epithelialization after endoscopic submucosal dissection (ESD) for esophageal cancer. Two clinical studies in Japan (19 cases) have been conducted, showing promising results with a high non-stenosis rate of 64%.
Show original Japanese text
患者自身の口腔粘膜から採取した上皮細胞を培養した細胞シートであり、食道がんにおける広範囲内視鏡的粘膜下層剥離術（ESD）後の狭窄の抑制及び再上皮化までの日数の短縮目的とするものである。国内で2つの臨床研究（19例）が実施されており、高い有効性を示唆する結果（本品の使用による高い非狭窄率64％）が得られた。
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.