From the Departments of Radiodiagnosis (V.B., V.G., N.K.).
From the Departments of Radiodiagnosis (V.B., V.G., N.K.)
AJNR Am J Neuroradiol. 2018 May;39(5):899-904. doi: 10.3174/ajnr.A5586. Epub 2018 Mar 15.
Stroke is a debilitating illness for which treatment window is limited. Most patients present to the healthcare facility beyond that window. Autologous stem cells have shown some promise for this group of patients. This study was performed to evaluate the safety and the efficacy of intra-arterial infusion of bone marrow-derived mononuclear cells in patients with middle cerebral artery ischemic stroke.
A prospective, randomized, open-label, blinded-end point study was performed from July 2015 to June 2016. Of 229 patients with acute stroke who presented to the hospital during this period, 20 patients who satisfied the inclusion/exclusion criteria were included and randomized into the control and intervention groups. Intra-arterial stem cell infusion into the ipsilateral MCA was performed in the patients in the intervention group at 8-15 days post-stroke ictus. Final analysis at 6 months was performed for primary (safety) and secondary outcomes (efficacy).
When we compared the primary end point of the study, no procedure-related mortality, complication, new infarct, or symptomatic intracranial hemorrhage was seen in the intervention group. When we compared the secondary end point of good clinical outcome, 8 (80%) patients in the intervention group showed good clinical outcome (modified Rankin Scale score < 2) with 4 (40%) patients in the control group achieving this (95% confidence interval for good outcome in patients with stem cell infusion, 49.03-94.3, and without stem cell infusion, 16.82-68.73; = .068).
Intra-arterial infusion of stem cells can be carried out safely in the subacute stage of ischemic stroke. Improved clinical outcomes were observed with intra-arterial stem cell therapy; however, studies with larger cohorts are needed to validate the results.
中风是一种使人衰弱的疾病，其治疗窗口有限。大多数患者在该窗口期后才到达医疗机构。自体干细胞已显示出对这组患者的一些希望。本研究旨在评估动脉内输注骨髓源性单核细胞治疗大脑中动脉缺血性中风患者的安全性和有效性。
2015 年 7 月至 2016 年 6 月进行了一项前瞻性、随机、开放标签、盲终点研究。在这段时间内，共有 229 名急性中风患者到医院就诊，其中 20 名符合纳入/排除标准的患者被纳入并随机分为对照组和干预组。在中风后 8-15 天，干预组患者进行同侧 MCA 内的动脉内干细胞输注。在 6 个月时对主要（安全性）和次要终点（疗效）进行最终分析。
当我们比较研究的主要终点时，干预组未出现与程序相关的死亡率、并发症、新梗死或症状性颅内出血。当我们比较良好临床结局的次要终点时，干预组有 8（80%）名患者表现出良好的临床结局（改良 Rankin 量表评分 < 2），对照组有 4（40%）名患者达到这一目标（接受干细胞输注患者的良好结局 95%置信区间为 49.03-94.3，未接受干细胞输注患者为 16.82-68.73； =.068）。
在缺血性中风的亚急性期，可以安全地进行动脉内干细胞输注。动脉内干细胞治疗观察到临床结局改善，但需要更大队列的研究来验证结果。
