九芝堂(000989.SZ):缺血耐受人同種異體骨髓間充質幹細胞獲《臨牀試驗通知書》
格隆匯2月19日丨九芝堂(000989.SZ)公佈,2019年11月20日,公司發佈《關於併購基金的投資進展公告》,九芝堂美科(北京)細胞技術有限公司(以下簡稱“美科公司”)收到國家藥品監督管理局簽發的《受理通知書》,缺血耐受人同種異體骨髓間充質幹細胞臨牀試驗申請已獲得國家藥品監督管理局受理。
近日,公司接併購基金通知,美科公司收到國家藥品監督管理局簽發的缺血耐受人同種異體骨髓間充質幹細胞《臨牀試驗通知書》(受理號:JXSL1900126)。
臨牀試驗產品缺血耐受人同種異體骨髓間充質幹細胞是由併購基金投資的美國Stemedica Cell Technologies Inc.(以下簡稱Stemedica)自主開發,生產過程符合美國FDA cGMP標準。該產品已在美國開展6項臨牀試驗,其中使用人骨髓間充質幹細胞治療缺血性卒中的I/IIa期臨牀試驗順利達到全部終點,初步證明了安全性和有效性,Stemedica使用人骨髓間充質幹細胞治療缺血性卒中的I/IIa期臨牀試驗研究論文發表在國際卒中領域專業雜誌Stroke上,在研究中獲得的詳細安全性和有效性數據已正式公佈。
美科公司此項臨牀試驗申請是目前國家藥品監督管理局藥品審評中心批准的第一項使用進口乾細胞產品的臨牀試驗申請,也是我國批准的第一項使用幹細胞治療神經系統疾病的臨牀試驗申請。
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