成果報告書詳細
管理番号20120000001148
タイトル*平成23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2012/12/19
報告書年度2011-2011
委託先名株式会社サイフューズ、国立大学法人九州大学
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。
英文要約Theme:Clinical research of 3D high density scaffold-free cell construct derived from adipose for osteochondral regeneration
Contractor:Cyfuse Biomedical K.K. and Kyushu University
This year’s achievements of research:
1. Establishment of the manufacturing procedures of 3D cell construct consists of human adipose derived stem cell(hereinafter referred to as “HDMAC”)
1) Clinical study for collecting adipose derived and bone marrow stem cell from healthy volunteers
After approval of conducting clinical study from the ethic committee on 22 Dec 2010, 3 healthy volunteers were registered and taken surgery for collecting adipose and bone marrow so far. No serious adverse events were observed.
2) Examination for manufacturing procedures and properties of HDMAC
Following manufacturing procedures and properties of HDMACs were examined using adipose-derived and bone-marrow-derived stem cell taken from the healthy volunteers
・Comparative analysis of stem cell growth rate derived from adipose and bone marrow
・Cultivation stem cell with or without serum
・Quality tests for production
・Differential ability tests
・Karyotyping
・DNA array analysis
・Analysis of cell properties
・Analysis of cell surface antigen
・Morphological observation, cell viability, the concentration of residual FBS, stability testing were examined to determine the standard of the final product. The draft of standard operating procedures for manufacturing HDMAC were prepared, and the process will be validated next year by the continuous research for remained 2 volunteers.
2. Non-clinical efficacy and safety research of adipose derived stem cell construct We conducted the non-clinical trials of grafting HDMAC in miniature swine. Pilot study has been started since Jan 2011 for 2 subjects. The safety and efficacy tests for grafting HDMAC on four swine were conducted. After the 6month observation period, three swine were being analyzed. Gross appearance of the regenerated cartilage were as good as healthy tissue. Further analysis are currently under examination and will be submitted in the next year.
3. Exploratory trial of grafting HDMAC for arthopathy patients based on the Japanese regulation for the clinical research using human stem cell We have drafted the protocol of the clinical research for grafting HDMAC to actual patient. The object of the clinical research are to evaluate safety and obtain proof of concept from small number of cases of osteochondral regeneration. The review by institutional review board (IRB) in Kyushu University and subsequent application to MHLW are planned in the next year.
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