Neuroprotective therapy using granulocyte colony-stimulating factor for acute spinal cord injury: a phase I/IIa clinical trial
Neuroprotective therapy using granulocyte colony-stimulating factor for acute spinal cord injury: a phase I/IIa clinical trial
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DOI：
10.1007/s00586-012-2213-3
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发表时间：
2012-12-01
影响因子：
2.8
通讯作者：
Koda, Masao
中科院分区：
文献类型：
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作者：
Takahashi, Hiroshi;Yamazaki, Masashi;Koda, Masao
粒细胞集落刺激因子（G-CSF）是一种细胞因子，临床上用于治疗中性粒细胞减少症。G-CSF还具有非造血功能，可能用于治疗神经元损伤。为了确认G-CSF给药治疗急性脊髓损伤（SCI）的安全性和可行性，我们已经启动了G-CSF神经保护治疗的I/IIa期临床试验。该试验共纳入16例发病48小时内的脊髓损伤患者。第一步，5例患者静脉给予g - csf （5 μ g/kg/天），连续5天。在第二步，同样给予11例患者g - csf （10 μ g/kg/天）。我们使用美国脊髓损伤协会（ASIA）评分和亚洲损伤量表（AIS）分级来评估患者的运动和感觉功能。所有16例患者在给予G-CSF后，神经系统均得到改善。16例患者中有9例AIS等级提高了一级。注射后第1天ASIA运动评分显著升高（P < 0.01），注射后第2天轻触和针刺评分均显著升高（P < 0.05）。注射G-CSF后未见严重不良反应。这些结果表明，静脉给药g - csf （10 μ g/kg/天）5天基本上是安全的，并提示大多数患者可能出现一定程度的神经功能恢复。我们认为G-CSF的管理可能是治疗急性脊髓损伤患者。
Granulocyte colony-stimulating factor (G-CSF) is a cytokine that is clinically used to treat neutropenia. G-CSF also has non-hematopoietic functions and could potentially be used to treat neuronal injury. To confirm the safety and feasibility of G-CSF administration for acute spinal cord injury (SCI), we have initiated a phase I/IIa clinical trial of neuroprotective therapy using G-CSF.The trial included a total of 16 SCI patients within 48 h of onset. In the first step, G-CSF (5 mu g/kg/day) was intravenously administered for 5 consecutive days to 5 patients. In the second step, G-CSF (10 mu g/kg/day) was similarly administered to 11 patients. We evaluated motor and sensory functions of patients using the American Spinal Cord Injury Association (ASIA) score and ASIA impairment scale (AIS) grade.In all 16 patients, neurological improvement was obtained after G-CSF administration. AIS grade increased by one step in 9 of 16 patients. A significant increase in ASIA motor scores was detected 1 day after injection (P < 0.01), and both light touch and pin prick scores improved 2 days after injection (P < 0.05) in the 10 mu g group. No severe adverse effects were observed after G-CSF injection.These results indicate that intravenous administration of G-CSF (10 mu g/kg/day) for 5 days is essentially safe, and suggest that some neurological recovery may occur in most patients. We suggest that G-CSF administration could be therapeutic for patients with acute SCI.