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First human randomized trial of G-CSF stem cellmobilization to treat large acute myocardial infarction-preliminary results of a pilot study

机译:第一个人类随机试验G-CSF干细胞培养治疗大型急性心肌梗死 - 试点研究的初步结果

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Based upon substantial preclinical testing, we initiated an FDA-sanctioned, single-site dose escalation study of gianulocyte colony stimulation factor (G-CSF) to attempt to enhance myocardial healing for patients with large acute MI via mobilization of stem cells Piincipal inclusion criteria were age < 80 yrs, acute ST elevation MI reperfused late (4-48 h), EF 20-39%, and coronary anatomy unlikely to require CABG Patients were randomized to G-CSF or placebo in a 2:1 fashion and treated for 5 days starting <48 h from MI onset.Initial daily SQ dose was 5 jig/kg day Primary safety and efficacy endpoints are rupture-free survival and change in EF to 30 days.To date, six patients have been randomized. Final results of this pilot study will provide important information upon which to base further trials of G-CSF in the setting of acute MI.
机译:基于大量的临床前测试,我们开始了对Giantogyte菌落刺激因子(G-CSF)的FDA制裁的单点剂量升级研究,以试图通过动员的干细胞纳入标准进行大规模MI患者来增强心肌愈合年龄<80 yrs,急性st海拔mi再灌注(4-48小时),效率20-39%,而且不太可能需要CABG患者的冠状动脉解剖学在2:1时装中随机化为G-CSF或安慰剂,并治疗5日期开始<48 h从MI发作。每日SQ剂量为5夹jig / kg日初级安全性和疗效终点是突破性的存活率和ef到30天的变化。迄今为止,六名患者已被随机化。该试点研究的最终结果将提供重要信息,在急性MI的环境中基于G-CSF的进一步试验。

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