Department of Neurology, Hospital Universitario Virgen del Rocío, Seville, Spain.
Stroke. 2012 Aug;43(8):2242-4. doi: 10.1161/STROKEAHA.112.659409. Epub 2012 Jul 3.
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.
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.
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 1.59×10(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 (β-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).
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.
www.clinicaltrials.gov. Unique identifier: NCT00761982.
骨髓单个核细胞（BM-MNC）动脉内移植可改善实验性缺血性卒中模型中的恢复。我们旨在评估自体 BM-MNC 移植治疗卒中患者的安全性、可行性和生物学效应。
对 10 例大脑中动脉卒中患者进行了单盲（结局评估者）对照的 I/II 期试验。在卒中后 5 至 9 天内经动脉内注射自体 BM-MNC。随访时间最长达 6 个月，并采集血样以检测生物学标志物。主要结局为该操作的安全性和可行性。次要结局为神经功能改善。
连续纳入 10 例（BM-MNC 治疗）和 10 例对照（BM-MNC 未治疗）患者。操作前平均国立卫生研究院卒中量表评分为 15.6。平均注射的 BM-MNC 为 1.59×10(8)。随访期间无死亡、卒中复发或肿瘤形成，尽管 2 例在 3 个月时有孤立性部分性癫痫发作。移植后，与对照组相比，β 神经生长因子（β-NGF）的血浆水平更高（P=0.02）。180 天时神经功能无显著差异。发现注射的 CD34+细胞数量与巴氏指数之间存在正相关趋势（r=0.56，P=0.09）。
亚急性期缺血性卒中患者经动脉内 BM-MNC 移植是可行的，且似乎是安全的。需要更大规模的随机试验来证实其安全性，并阐明 BM-MNC 移植的疗效。
