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聖濟堂(600227.SH):中觀生物人臍帶間充質幹細胞注射液獲批開展治療膝骨關節炎的臨牀試驗
格隆匯 06-20 17:42

格隆匯6月20日丨聖濟堂(600227.SH)公佈,2022年6月20日,貴州聖濟堂醫藥產業股份有限公司控股子公司貴州中觀生物技術有限公司(簡稱“中觀生物”)收到國家藥品監督管理局核准簽發關於人臍帶間充質幹細胞注射液的《藥物臨牀試驗批准通知書》,同意開展治療膝骨關節炎的臨牀試驗。

人臍帶間充質幹細胞注射液是由中觀生物自主研發的間充質幹細胞注射劑。人臍帶間充質幹細胞是一種來源於人臍帶“WHARTON’SJELLY(華通氏膠)”的間充質幹細胞,具有一般MSCS特性,包括自我更新、多向分化、免疫調控、造血支持、分泌多種細胞因子、抗菌作用、低免疫原性、損傷修復、未見成瘤性等。同時,人臍帶間充質幹細胞還具有來源不受倫理道德爭議的特點(廢棄生物材料)。其中,具有分化成脂肪、骨、軟骨等多種成體細胞的多譜系分化能力,並能分泌出具有再生功能的營養因子,被認為是軟骨再生的理想候選細胞,現已被應用於免疫和炎症性疾病。中觀生物自主研發的人臍帶間充質幹細胞注射液主要依靠人臍帶間充質幹細胞的自我更新、多向分化、免疫調控、低免疫原性、損傷修復及分泌多種細胞因子的功能進行膝骨關節炎治療。

截止至目前,該項目已累計投入研發費用為928.54萬元人民幣。

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