聖濟堂(600227.SH):胎盤羊膜間充質幹細胞六個批次《檢驗報告》結論均合格
格隆匯11月3日丨聖濟堂(600227.SH)公佈,2020年11月3日,公司控股子公司中觀生物收到中檢院頒發的胎盤羊膜間充質幹細胞《檢驗報告》。
中檢院是國家檢驗藥品生物製品質量的法定機構和最高技術仲裁機構,具有實驗室認可(CNAS)和資質認定(CMA)資格的國家級檢定實驗室。這是中觀生物送檢的第二、三批次胎盤羊膜間充質幹細胞樣品,分別為人胎盤羊膜間充質幹細胞hAMSC-128第5代(P5)、第10代(P10)及hAMSC-149第5代(P5)、第10代(P10)。
截止本公告披露之日,中觀生物已完成三批次臍帶間充質幹細胞和三批次胎盤羊膜間充質幹細胞報檢工作,六個批次的《檢驗報告》結論均合格。
目前,中觀生物按照《幹細胞臨牀研究管理辦法(試行)》、《體細胞治療臨牀研究和轉化應用管理辦法(試行)》、《關於做好2019年幹細胞臨牀研究監督管理工作的通知》等規定,與貴州醫科大學附屬醫院合作申報的人臍帶間充質幹細胞治療2型糖尿病和人臍帶間充質幹細胞治療類風濕性關節炎臨牀研究項目已通過貴州省衞生健康委員會備案,並報國家衞生健康委員會申請備案。
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