成果報告書詳細
管理番号20110000000923
タイトル*平成22年度中間年報 基礎研究から臨床研究への橋渡し促進技術開発/橋渡し促進技術開発 高密度スキャフォールドフリー脂肪由来幹細胞構造体を用いた骨軟骨組織再生の臨床研究
公開日2011/6/23
報告書年度2010 - 2010
委託先名国立大学法人九州大学 株式会社サイフューズ
プロジェクト番号P07022
部署名バイオテクノロジー・医療技術部
和文要約和文要約等以下本編抜粋:1. 研究開発の内容及び成果等 事業項目1:ヒト脂肪組織由来幹細胞構造体の製造方法の確立 本項目では、ヒト脂肪組織から分離した幹細胞で細胞構造体を製造する工程の条件検討、細胞構造体の品質確認を行い、GMPに準拠した製造工程を確立したうえで、細胞構造体のスペックを決定することを目的とする。 1)ヒト組織採取の為の探索的臨床研究の実施(担当:九州大学) 本研究開発責任者である松田秀一を試験責任医師とし、細胞構造体製造工程の検証に使用する組織を健常人被験者から採取する探索的臨床研究を実施する。
英文要約Title: Clinical research of 3D high density scaffold-free cell construct derived from adipose for osteochondral regeneration (FY2010-FY2012) FY2010 Annual Report
1. Establishment of the manufacturing procedures of 3D cell construct consists of human adipose derived stem cell : To graft the stem cell construct for the defective or injured site of patients’ knee in future, the manufacturing procedures of cell construct should be examined and then validated reproducibly using human tissue collected from healthy volunteers. Ethic committee of Kyushu University approved to conduct the clinical research on 22 Dec 2010. The purpose of this clinical research is to collect adipose and bone marrow from 5 healthy volunteers to assess the feasibility of the production of human cell construct as well as non-clinical tests. First healthy volunteer was registered, and his adipose and bone marrow were collected. As the result of cultivation of both stem cell separated from those tissue, adipose derived stem cell showed faster cell growth than bone marrow stem cell, and the feasibility of the production of 3D cell construct was confirmed. Additionally, the quality test results indicated that manufacturing procedures were succeeded without contamination, and other tests like karyotyping, FACS and differential ability tests were conducted to evaluate the quality and safety of the cell construct. The draft of standard operating procedures for manufacturing cell construct compliance with the GMP were prepared, and the process will be brush up and validated next year by the continuous clinical research for remained 4 subjects. 2. Non-clinical efficacy and safety research of adipose derived stem cell construct : For applying the conduction of clinical trial using human stem cell to the Japanese regulatory office, safety and efficacy data of 3D cell construct should be presented in non-clinical research in advance. Therefore, we contracted with a company to conduct the trial of grafting autologous adipose-derived stem cell construct in miniature swine. Pilot study has been started since Jan 2011 for 2 subjects. Next year, safety and efficacy tests for cell construct on 3 swine are planned. 3. Exploratory trial of grafting the 3D cell construct for arthopathy patients based on the Japanese regulation for the clinical trials using human stem cell : We have begun preparation for the application of clinical trial to the regulatory office. We consulted the officer in MHLW about the trial design and the data package of non-clinical studies, and the rough outline of the exploratory trial of grafting cell construct in actual patients have joint disease were determined. Further discussion will be held in next year and the application documents will be prepared.
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