STROKE34 Study Protocol: A Randomized Controlled Phase IIa Trial of Intra-Arterial CD34+ Cells in Acute Ischemic Stroke
STROKE34 Study Protocol: A Randomized Controlled Phase IIa Trial of Intra-Arterial CD34+ Cells in Acute Ischemic Stroke
复制标题
STROKE34 研究方案：动脉内 CD34+ 细胞治疗急性缺血性中风的随机对照 IIa 期试验
作者：
J. Sargento;A. Pereira;A. Gomes;Paula Amorim;T. Matos;Carla M P Cardoso;F. Silva;G. Santo;C. Nunes;O. Galego;J. Carda;J. Branco;Víctor Lourenço;L. Cunha;Lino Ferreira
原理/目的尽管再通治疗对急性缺血性卒中的疗效不断提高，但大量患者仍存在长期功能障碍，缺乏有效治疗。CD 34+细胞包括骨髓来源的单核细胞的一个子集，具有促进缺血性病变中血管生成的能力，并且在观察性和体外研究中显示出有希望的结果。在这项研究中，我们的目的是评估CD 34+细胞自体移植在急性缺血性卒中中的疗效。样本量估计为30例患者将随机分组，把握度为90%，α为0.05，以检测3个月梗死体积的差异。方法和设计：我们将筛选18-80岁的大脑中动脉（MCA）闭塞所致急性缺血性卒中患者进行随机分组。将排除持续性动脉闭塞、磁共振成像（MRI）禁忌症、病前依赖或其他严重疾病。治疗将包括骨髓抽吸、选择CD 34+细胞，并通过血管造影术在症状性MCA中动脉内给药。患者将在7（±2）天、20（±5）天或假手术时随机接受治疗，每组10例。研究结果主要结果将是3个月时进行的MRI中的梗死体积。次要结局将包括不良事件和多维功能和神经系统指标。讨论/结论STROKE 34是一项PROBE设计的IIa期临床试验，旨在评估急性缺血性卒中后7天和20天动脉内给予CD 34+细胞的疗效。试验注册（欧盟临床试验注册）2017-002456-88。
Rationale/aim Despite the increasing efficacy of recanalization therapies for acute ischemic stroke, a large number of patients are left with long-term functional impairment, devoid of efficacious treatments. CD34+ cells comprise a subset of bone marrow-derived mononuclear cells with the capacity to promote angiogenesis in ischemic lesions and have shown promising results in observational and in vitro studies. In this study, we aim to assess the efficacy of an autotransplant of CD34+ cells in acute ischemic stroke. Sample size estimates 30 patients will be randomized for a power of 90% and alpha of 0.05 to detect a difference in 3 months infarct volume. Methods and design We will screen 18–80 years old patients with acute ischemic stroke due to occlusion of a middle cerebral artery (MCA) for randomization. Persistent arterial occlusions, contra-indications to magnetic resonance imaging (MRI), premorbid dependency, or other severe diseases will be excluded. Treatment will involve bone marrow aspiration, selection of CD34+ cells, and their administration intra-arterially in the symptomatic MCA by angiography. Patients will be randomized for treatment at 7 (±2) days, 20 (±5 days) or sham procedure, 10 in each group. Study outcomes The primary outcome will be infarct volume in MRI performed at 3 months. Secondary outcomes will include adverse events and multidimensional functional and neurological measures. Discussion/conclusion STROKE34 is a PROBE design phase IIa clinical trial to assess the efficacy of intra-arterial administration of CD34+ cells 7 and 20 days after acute ischemic stroke. Trial registration (EU Clinical Trials Register) 2017-002456-88.
影响因子：
15.9
作者：
Zhang, ZG;Zhang, L;Chopp, M
通讯作者：
Chopp, M