Moniche Francisco, Escudero Irene, Zapata-Arriaza Elena, Usero-Ruiz María, Prieto-León María, de la Torre Javier, Gamero Miguel-Angel, Tamayo Jose Antonio, Ochoa-Sepúlveda Juan-José, Maestre José, Carmona Magdalena, Piñero Pilar, Calderón-Cabrera Cristina, Jimenez Maria-Dolores, Gonzalez Alejandro, Montaner Joan
Department of Neurology, Hospital Universitario Virgen del Rocío, Seville, Spain.
Department of Neurology, Hospital Universitario Virgen Macarena, Seville, Spain.
Int J Stroke. 2015 Oct;10(7):1149-52. doi: 10.1111/ijs.12520. Epub 2015 Jun 4.
No neuroprotective or neurorestorative therapies have been approved for ischemic stroke. Bone marrow mononuclear cell intra-arterial transplantation improves recovery in experimental models of ischemic stroke.
This trial aims to test safety and efficacy of intra-arterial injection of autologous bone marrow mononuclear cell in ischemic stroke patients.
Multicenter, prospective, phase II, randomized, controlled (non-treated group as control), assessor-blinded clinical trial. Seventy-six stroke patients will be enrolled. Patients fulfilling clinical and radiological criteria (e.g. age between 18 and 80 years, middle cerebral artery ischemic stroke with a National Institutes of Health Stroke Scale score of 6-20 within one- to seven-days from stroke onset and no lacunar stroke) will be randomized to intervention or control group (1 : 1). Bone marrow harvest and intra-arterial injection of autologous bone marrow mononuclear cell will be done in the intervention group with two different doses (2 × 10(6) /kg or 5 × 10(6) /kg in 1 : 1 proportion). Patients will be stratified at randomization by National Institutes of Health Stroke Scale score. Patients will be followed up for two-years.
The primary outcome is the proportion of patients with modified Rankin Scale scores of 0-2 at 180 days. Secondary outcomes include National Institutes of Health Stroke Scale and Barthel scores at six-months, infarct volume, mortality, and seizures.
This is the first trial to explore efficacy of different doses of intra-arterial bone marrow mononuclear cell in moderate-to-severe acute ischemic stroke patients. The trial is registered as NCT02178657.
尚无神经保护或神经修复疗法被批准用于缺血性中风。骨髓单个核细胞动脉内移植可改善缺血性中风实验模型中的恢复情况。
本试验旨在测试动脉内注射自体骨髓单个核细胞对缺血性中风患者的安全性和有效性。
多中心、前瞻性、II期、随机、对照（以未治疗组作为对照）、评估者盲法临床试验。将招募76名中风患者。符合临床和影像学标准（如年龄在18至80岁之间、大脑中动脉缺血性中风、中风发作后1至7天内美国国立卫生研究院卒中量表评分为6 - 20且非腔隙性中风）的患者将被随机分为干预组或对照组（1∶1）。干预组将以两种不同剂量（2×10⁶/kg或5×10⁶/kg，比例为1∶1）进行自体骨髓单个核细胞的骨髓采集和动脉内注射。患者将在随机分组时按美国国立卫生研究院卒中量表评分进行分层。患者将接受为期两年的随访。
主要结局是180天时改良Rankin量表评分为0 - 2的患者比例。次要结局包括6个月时的美国国立卫生研究院卒中量表和Barthel评分、梗死体积、死亡率和癫痫发作。
这是首个探索不同剂量动脉内骨髓单个核细胞对中重度急性缺血性中风患者疗效的试验。该试验已注册，注册号为NCT02178657。
