{"data":[{"id":"be65330f-d8fa-41f7-92f6-7084595d318d","company_name":"株式会社 ヘリオス","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":"ヒト（同種）成人骨髄由来多能性前駆細胞 脳梗塞急性期（発症後18～36時間）","violation_summary_en":"Human (same species) adult bone marrow-derived pluripotent precursor cells for acute phase cerebral infarction (18 to 36 hours after onset)","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-heriosu-20171005"},{"id":"b230971f-1bba-4142-9cc1-21cbae664e61","company_name":"株式会社ヘリオス","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":"急性期（発症後18～36時間）の脳梗塞の治療を目的とした、ドナーの骨髄から採取して増殖させた成人接着性幹細胞に由来する幹細胞製品。","violation_summary_en":"The Ministry of Health, Labour and Welfare designated a stem cell product derived from donor bone marrow, intended for treating acute ischemic stroke within 18-36 hours of onset, as a regulated medical product under the Pharmaceutical and Medical Device Act on February 28, 2017.","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-heriosu-20170228"},{"id":"d5f18eeb-97d9-4463-aa53-3fc8514c75f9","company_name":"株式会社ヘリオス","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":"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。","violation_summary_en":"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.","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-heriosu-20170228"}],"meta":{"query":"株式会社ヘリオス","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":"2026-08-04T17:39:29.290Z"},"daily_rate_limit":{"limit":300,"window_seconds":86400,"remaining":109,"reset_at":"2026-08-05T17:38:29.290Z"}}}