成果報告書詳細
管理番号20140000000401
タイトル*平成25年度中間年報 「次世代機能代替技術の研究開発 次世代再生医療技術の研究開発 有効性・安全性評価技術等の開発(生体内で自律的に成熟する臓器再生デバイスのための評価技術研究開発)」
公開日2014/8/20
報告書年度2013 - 2013
委託先名国立大学法人東京大学 株式会社ツーセル 学校法人福田学園
プロジェクト番号P10004
部署名バイオテクノロジー・医療技術部
和文要約
英文要約Title: Research Project of assessment technology for Autonomous Regeneration Device (FY2010-FY2014) FY2013 Annual Report

Reconstruction of joints, based on autonomous regeneration of cartilages, would enable to promote generalization and industrialization of cartilage tissue engineering. In this project, we will establish an assessment technology to apply the autonomous regeneration for reconstruction of joints. For that purpose, we have carried out research and development described below this year. As assessment technology concerning safety of cultured cells, MSC, MSC derived from synovium and fibroblasts of the active form vitamin D3 responsiveness in serum culture system or no serum culture system were evaluated. In addition, we studied and developed new genetic markers. We tested the 3 clinical research cases at Osaka University Hospital using those markers by Real Time PCR. As assessment technology concerning safety of autonomous regeneration device, we evaluated the ability of cartilage formation in the cartilage and bone defect model of pigs. After transplantation for 1, 14, 28, 56 days, we evaluated the effectiveness of the autonomous regeneration device by the clinical signs of the weight, flare, swelling, wound and bearing from grade 0 to 4. We also defined levels of cartilage regeneration from grade 0 to grade 4 by histological analyses and evaluated the formation of regenerated cartilage with µCT, soft X-ray. In cooperation with Fuji Soft Co., Ltd. in charge of the industrialization, we are able to apply evaluations technology Fuji Soft has already established to this project, such as the regeneration devise technology and the culture product management technology. As establishment of an evaluation guideline for autonomous regeneration device, we investigated the trend of the evaluation index plan established in Europe and America (FDA, European pharmaceutical station) and analyzed the modification in the evaluation index of performed FDA of the revision. In addition, we reviewed the international trend of the quantitative and qualitative rating system by the MRI for the purpose of evaluating the quality of the organization after the transplantation noninvasively.
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