Cardiac Stem Cell Laboratory and Catheterization Laboratory, Rigshospitalet, Copenhagen University Hospital, Denmark.
Am Heart J. 2012 Sep;164(3):285-91. doi: 10.1016/j.ahj.2012.05.026.
Stem cell therapy is an emerging treatment modality in cardiovascular disease. The best cell type and delivery method in different cardiovascular diseases remain to be determined.
The MSC-HF trial is a phase 2, single-center, double-blind, randomized, placebo-controlled trial of intramyocardial delivery of autologous bone-marrow derived mesenchymal stromal cells (MSCs) in patients with chronic ischemic heart failure. A total of 60 patients will be randomized in a 2:1 pattern to receive intramyocardial injections of either MSCs or placebo. Patients will be followed up for 12 months.
Bone marrow will be obtained by aspiration from the iliac crest. Mesenchymal stromal cells will be isolated, and culture will be expanded for 6 to 8 weeks. A total of 12 to 15 MSC or placebo injections will be placed in an ischemic viable region of the myocardium using the electromechanical NOGA-XP system (Biologics Delivery Systems Group, Johnson & Johnson, Irwindale, CA).
The primary endpoint is change in left ventricle end-systolic volume, measured by magnetic resonance imaging (MRI) or computed tomography (CT) at 6-month follow-up. Secondary endpoints are left ventricle ejection fraction, ventricular volumes, wall thickness, and systolic wall thickening measured by MRI or CT in addition to measurement of myocardial scar tissue by MRI. Other secondary endpoints are safety of treatment, clinical symptoms and functional capacity, weekly angina attacks, use of short-term nitroglycerine, and quality of life.
A randomized, double-blind, placebo-controlled, clinical trial of intramyocardial delivery of MSCs in patients with ischemic heart failure has been set up to confirm the positive findings in open-labeled clinical trials.
干细胞疗法是心血管疾病中一种新兴的治疗方式。在不同的心血管疾病中，最佳的细胞类型和输送方法仍有待确定。
MSC-HF 试验是一项 2 期、单中心、双盲、随机、安慰剂对照试验，旨在评估自体骨髓来源间充质基质细胞（MSCs）经心肌内注射治疗慢性缺血性心力衰竭患者的疗效。共有 60 例患者将以 2:1 的比例随机分为接受 MSCs 或安慰剂心肌内注射的两组。患者将接受为期 12 个月的随访。
通过髂嵴抽吸获得骨髓。分离间充质基质细胞，并进行 6 至 8 周的培养扩增。使用电机械 NOGA-XP 系统（Biologics Delivery Systems Group，Johnson & Johnson，Irwindale，CA）将总共 12 至 15 次 MSC 或安慰剂注射到心肌缺血的存活区域。
主要终点是通过磁共振成像（MRI）或计算机断层扫描（CT）在 6 个月随访时测量的左心室收缩末期容积变化。次要终点是左心室射血分数、心室容积、壁厚度和收缩期壁增厚，通过 MRI 或 CT 测量，此外还通过 MRI 测量心肌瘢痕组织。其他次要终点是治疗的安全性、临床症状和功能能力、每周心绞痛发作、短期硝酸甘油的使用以及生活质量。
已经建立了一项随机、双盲、安慰剂对照的临床试验，以评估缺血性心力衰竭患者经心肌内注射 MSCs 的疗效，旨在证实开放标签临床试验的阳性结果。
