Granulocyte-Colony Stimulating Factor for Mobilizing Bone Marrow Stem Cells in Subacute Stroke The Stem Cell Trial of Recovery Enhancement After Stroke 2 Randomized Controlled Trial
Granulocyte-Colony Stimulating Factor for Mobilizing Bone Marrow Stem Cells in Subacute Stroke The Stem Cell Trial of Recovery Enhancement After Stroke 2 Randomized Controlled Trial
复制标题
DOI：
10.1161/strokeaha.111.636449
复制
发表时间：
2012-02-01
期刊：
影响因子：
8.3
通讯作者：
Bath, Philip M. W.
中科院分区：
文献类型：
--
作者：
England, Timothy J.;Abaei, Maryam;Bath, Philip M. W.
背景与目的：粒细胞集落刺激因子(G-CSF)对实验性卒中具有神经保护作用，能动员CD34(+)外周血干细胞进入循环。方法60例缺血性或出血性卒中患者于卒中后3~30天分别给予G-CSF(10µg/kg)或安慰剂(2：1)SC，疗程5天。主要结果是严重不良事件的发生频率。测量外周血计数、CD34(+)计数和功能结果。结果：60例患者平均发病后8天(SD+/-5)，平均年龄71岁(+/-12岁)，男性占53%。两组在基线最小化/预后因素方面匹配良好。在严重不良事件的参与者数量方面，两组之间没有显著差异：40例中有15例(37.5%)，20例中有7例(35%)服用安慰剂，90天时死亡或依赖(修正的Rankin评分：G-CSF3.3+/-1.3，安慰剂3.0+/-1.3)，或接受注射的次数。G-CSF使CD34(+)和白细胞总数分别增加了9.5倍和4.2倍。在接受G-CSF治疗的患者中，相对于基线的变化，MRI缺血病变体积有减小的趋势(P=0.06)。在1名参与者中，有迹象表明标记的CD34(+)细胞已经迁移到缺血灶。结论--这项随机、双盲、安慰剂对照试验表明，亚急性给药时G-CSF是安全的。在缺血性卒中患者中标记和重新管理铁标记的CD34(+)细胞是可行的。
Background and Purpose-Granulocyte-colony stimulating factor (G-CSF) is neuroprotective in experimental stroke and mobilizes CD34(+) peripheral blood stem cells into the circulation. We assessed the safety of G-CSF in recent stroke in a phase lib single-center randomized, controlled trial.Methods-G-CSF (10 mu g/kg) or placebo (ratio 2:1) was given SC for 5 days to 60 patients 3 to 30 days after ischemic or hemorrhagic stroke. The primary outcome was the frequency of serious adverse events. Peripheral blood counts, CD34(+) count, and functional outcome were measured. MRI assessed lesion volume, atrophy, and the presence of iron-labeled CD34(+) cells reinjected on day 6.Results-Sixty patients were recruited at mean of 8 days (SD +/- 5) post ictus, with mean age 71 years (+/- 12 years) and 53% men. The groups were well matched for baseline minimization/prognostic factors. There were no significant differences between groups in the number of participants with serious adverse events: G-CSF 15 (37.5%) of 40 versus placebo 7 (35%) of 20, death or dependency (modified Rankin Score: G-CSF 3.3 +/- 1.3, placebo 3.0 +/- 1.3) at 90 days, or the number of injections received. G-CSF increased CD34(+) and total white cell counts of 9.5- and 4.2-fold, respectively. There was a trend toward reduction in MRI ischemic lesion volume with respect to change from baseline in G-CSF-treated patients (P=0.06). In 1 participant, there was suggestion that labeled CD34(+) cells had migrated to the ischemic lesion.Conclusions-This randomized, double-blind, placebo-controlled trial suggests that G-CSF is safe when administered subacutely. It is feasible to label and readminister iron-labeled CD34(+) cells in patients with ischemic stroke.