Intra-Arterial Bone Marrow Mononuclear Cells in Ischemic Stroke A Pilot Clinical Trial
Intra-Arterial Bone Marrow Mononuclear Cells in Ischemic Stroke A Pilot Clinical Trial
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DOI：
10.1161/strokeaha.112.659409
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发表时间：
2012-08-01
期刊：
影响因子：
8.3
通讯作者：
Gil-Peralta, Alberto
中科院分区：
文献类型：
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作者：
Moniche, Francisco;Gonzalez, Alejandro;Gil-Peralta, Alberto
背景和目的：骨髓单个核细胞（BM-MNC）动脉内移植改善缺血性卒中实验模型的恢复。我们的目的是评估安全性，可行性，自体骨髓-MNC移植在中风patients.Methods-A单盲（结果评估）对照I/II期临床试验的生物学效应进行了大脑中动脉中风患者。在中风后5至9天之间动脉内注射自体BM-MNCs。随访时间长达6个月，并采集血液样本进行生物学标记。主要结局是手术的安全性和可行性。次要结果是神经功能的改善。结果10例（BM-MNC治疗）和10例对照受试者（BM-MNC未治疗）被连续纳入。术前美国国立卫生研究院卒中量表的平均评分为15.6分。注射的平均BM-MNC为1.59 x 10（8）。随访期间无死亡、卒中复发或肿瘤形成，但2例患者在3个月时出现孤立性部分性癫痫发作。移植后，与对照组相比，发现血浆β神经生长因子（β-神经生长因子）水平较高（P = 0.02）。在180天时，神经功能无显著差异。CD 34+细胞注射量与Barthel指数呈显著正相关（r = 0.56，P = 0.09）。BM-MNC移植的安全性和有效性尚需进一步的随机试验证实。
Background and Purpose-Bone marrow mononuclear cell (BM-MNC) intra-arterial transplantation improves recovery in experimental models of ischemic stroke. We aimed to assess the safety, feasibility, and biological effects of autologous BM-MNC transplantation in patients with stroke.Methods-A single-blind (outcomes assessor) controlled Phase I/II trial was conducted in patients with middle cerebral artery stroke. Autologous BM-MNCs were injected intra-arterially between 5 and 9 days after stroke. Follow-up was done for up to 6 months and blood samples were collected for biological markers. The primary outcome was safety and feasibility of the procedure. The secondary outcome was improvement in neurological function.Results-Ten cases (BM-MNC-treated) and 10 control subjects (BM-MNC-nontreated) were consecutively included. Mean National Institutes of Health Stroke Scale before the procedure was 15.6. Mean BM-MNCs injected were 1.59 x 10(8). There was no death, stroke recurrence, or tumor formation during follow-up, although 2 cases had an isolate partial seizure at 3 months. After transplantation, higher plasma levels of beta nerve growth factor (beta-nerve growth factor) were found compared with control subjects (P = 0.02). There were no significant differences in neurological function at 180 days. A trend to positive correlation between number of CD34+ cells injected and Barthel Index was found (r = 0.56, P = 0.09).Conclusions-Intra-arterial BM-MNC transplantation in subacute ischemic stroke is feasible and seems to be safe. Larger randomized trials are needed to confirm the safety and elucidate the efficacy of BM-MNC transplantation.