Enforcement record
指定 disclosure naming 株式会社セルシード
This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.
Action type
指定
Law
Pharmaceutical Affairs Act
Authority
Ministry of Health, Labour and Welfare
Action date
28 February 2017
Current page: Enforcement record
This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.
Source verification
Public-source and preservation status
- Publishing authority
- Ministry of Health, Labour and Welfare
- Official source URL
- Recorded by RegBase
- Entity match
- Not confirmed; shown under the published name
- Kiroku preservation
- Queued for preservation
- Captured: Jul 12, 2026, 04:04 PM JST
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Action summary
- Company
- 株式会社セルシードJapanese onlyOriginal: 株式会社セルシード
- Governing law
- Pharmaceutical Affairs Act薬事法
- Action type
- 指定指定
- Action date
- 28 February 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。
Compliance context
Context neededThis is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.
Japanese regulatory disclosure under Pharmaceutical Affairs Act.
Review the original Japanese source and determine relevance to your counterparty-risk workflow.
This context is an operational aid for review workflows, not a credit opinion or legal conclusion.
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.