AIMS The study assessed 4-year outcomes of intramyocardial injections of autologous bone marrow-derived mesenchymal stromal cells (MSCs) in patients with ischaemic heart failure. METHODS AND RESULTS The MSC-HF trial was a randomized, double-blind, placebo-controlled trial. Patients were randomized 2:1 to intramyocardial injections of MSCs or placebo. The primary endpoint was change in left ventricular end-systolic volume (LVESV), measured by magnetic resonance imaging or computed tomography. Sixty patients aged 30-80 years with ischaemic heart failure, New York Heart Association class II-III, left ventricular ejection fraction (LVEF) <45% and no further treatment options were randomized. Patients were followed clinically for 12 months and in addition 4-year data of hospitalizations and survival were retrieved. After 12 months, LVESV was significantly reduced in the MSC group and not in the placebo group, with difference between groups of 17.0 ± 16.2 mL (95% confidence interval 8.3-25.7, P = 0.0002). There were also significant improvements in LVEF of 6.2% (P < 0.0001), stroke volume of 16.1 mL (P < 0.0001) and myocardial mass (P = 0.009) between groups. A significant dose-response effect was also observed. Moreover, a significant reduction in the amount of scar tissue and quality of life score in the MSC group but not in the placebo group was observed. After 4 years, there were significantly fewer hospitalizations for angina in the MSC group and otherwise no differences in hospitalizations or survival. No side effects were identified. CONCLUSIONS Intramyocardial injections of autologous bone marrow-derived MSCs improved myocardial function and myocardial mass in patients with ischaemic heart failure.

中文翻译：

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缺血性心力衰竭患者的骨髓间充质基质细胞治疗：MSC-HF试验的最后4年随访。

目的该研究评估了缺血性心力衰竭患者心肌内注射自体骨髓源间充质基质细胞（MSCs）的4年结局。方法和结果MSC-HF试验是一项随机，双盲，安慰剂对照试验。患者按2：1随机接受心肌内注射MSC或安慰剂。主要终点是通过磁共振成像或计算机断层扫描测量的左心室收缩末期容积（LVESV）的变化。60名年龄在30-80岁的缺血性心力衰竭患者，纽约心脏协会II-III级，左心室射血分数（LVEF）<45％，并且没有进一步的治疗选择。临床上对患者进行了12个月的随访，此外还检索了4年的住院和生存数据。12个月后，MSC组而非安慰剂组LVESV显着降低，两组之间的差异为17.0±16.2 mL（95％置信区间8.3-25.7，P = 0.0002）。两组之间的LVEF显着改善（6.2％（P <0.0001），中风量16.1 mL（P <0.0001）和心肌质量（P = 0.009）。还观察到显着的剂量反应作用。此外，在MSC组中观察到疤痕组织的数量和生活质量得分显着降低，而在安慰剂组中则没有观察到。四年后，MSC组的心绞痛住院率显着降低，否则住院率或生存率没有差异。没有发现副作用。