{"data":[{"id":"22decbb2-afc2-46f9-b61d-789b8c612f49","company_name":"株式会社 セルシード","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["先駆け審査指定制度対象品目の募集"],"regional_record_count":1,"source_document_count":1,"law_name":"薬事法","action_type":"先駆け審査指定制度対象品目の募集","action_date":"2017-10-05","announcement_date":"2026-04-03","violation_summary":"口腔粘膜由来食道細胞シート 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","violation_summary_en":"Suppression of stenosis and reduction of days until re-epithelialization after endoscopic submucosal dissection (ESD) for esophageal cancer using oral mucosa-derived esophageal cell sheet","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":60,"method":"extracted_japanese_name","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/houdou/0000179802.html","url":"https://regbase.jp/enforcement/other-serusido-20171005"},{"id":"c2e33dfb-6e30-46f1-bf14-45a97b3744de","company_name":"株式会社セルシード","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["指定"],"regional_record_count":1,"source_document_count":1,"law_name":"薬事法","action_type":"指定","action_date":"2017-02-28","announcement_date":"2026-04-07","violation_summary":"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。","violation_summary_en":"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%.","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":60,"method":"extracted_japanese_name","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/houdou/0000153128.html","url":"https://regbase.jp/enforcement/other-serusido-20170228"},{"id":"28af3b43-48e0-44e9-94fc-a13ca7ad7299","company_name":"株式会社セルシード","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["指定"],"regional_record_count":1,"source_document_count":1,"law_name":"薬機法","action_type":"指定","action_date":"2017-02-28","announcement_date":"2026-05-02","violation_summary":"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。","violation_summary_en":"The company was designated under the Pharmaceutical and Medical Device Act on February 28, 2017, for its cell sheet product cultured from the patient's own oral mucosal epithelial cells, intended to prevent esophageal stricture and shorten re-epithelialization time after endoscopic submucosal dissection (ESD) for esophageal cancer.","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":60,"method":"extracted_japanese_name","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/houdou/0000153128.html","url":"https://regbase.jp/enforcement/yakkiho-serusido-20170228"}],"meta":{"query":"株式会社セルシード","corporate_number":null,"law":null,"authority":null,"action_type":null,"count":3,"api_docs":"https://regbase.jp/api-docs","openapi_schema":"https://regbase.jp/api/openapi.json","llms":"https://regbase.jp/llms.txt","usage_note":"Use RegBase for targeted public-source screening of Japanese companies and enforcement records. Absence of returned records is not a clearance, legal opinion, sanctions result, or credit decision.","rate_limit":{"limit":10,"window_seconds":60,"remaining":7,"reset_at":"2026-08-04T18:34:56.305Z"},"daily_rate_limit":{"limit":300,"window_seconds":86400,"remaining":64,"reset_at":"2026-08-05T18:33:56.305Z"}}}