Background Most cell therapy trials failed to show an improvement in global left ventricular (LV) function measures after myocardial infarction (MI). Myocardial segments are heterogeneously impacted by MI. Global LV function indices are not able to detect the small treatment effects on segmental myocardial function which may have prognostic implications for cardiac events. We aimed to test the efficacy of allogeneic cardiosphere-derived cells (CDCs) for improving regional myocardial function and contractility. Methods In this exploratory analysis of a randomised clinical trial, 142 patients with post-MI with LVEF <45% and 15% or greater LV scar size were randomised in 2:1 ratio to receive intracoronary infusion of allogenic CDCs or placebo, respectively. Change in segmental myocardial circumferential strain (Ecc) by MRI from baseline to 6 months was compared between CDCs and placebo groups. Results In total, 124 patients completed the 6-month follow-up (mean (SD) age 54.3 (10.8) and 108 (87.1%) men). Segmental Ecc improvement was significantly greater in patients receiving CDC (−0.5% (4.0)) compared with placebo (0.2% (3.7), p=0.05). The greatest benefit for improvement in segmental Ecc was observed in segments containing scar tissue (change in segmental Ecc of −0.7% (3.5) in patients receiving CDC vs 0.04% (3.7) in the placebo group, p=0.04). Conclusions In patients with post-MI LV dysfunction, CDC administration resulted in improved segmental myocardial function. Our findings highlight the importance of segmental myocardial function indices as an endpoint in future clinical trials of patients with post-MI. Trial registration number [NCT01458405][1]. No data are available. The authors declare that the supporting data for this manuscript will not be available to other researchers. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01458405&atom=%2Fopenhrt%2F8%2F2%2Fe001614.atom

中文翻译：

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心源性细胞对心肌梗死后节段性心肌功能的影响：ALLSTAR随机临床试验

背景 大多数细胞治疗试验未能显示心肌梗死 (MI) 后整体左心室 (LV) 功能指标的改善。心肌节段受到 MI 的影响存在异质性。整体左心室功能指数无法检测对节段心肌功能的微小治疗影响，这可能对心脏事件的预后产生影响。我们的目的是测试同种异体心肌源性细胞（CDC）改善局部心肌功能和收缩力的功效。方法 在这项随机临床试验的探索性分析中，142 名 LVEF <45% 且 LV 疤痕大小为 15% 或更大的 MI 后患者按 2:1 的比例随机分配，分别接受同种异体 CDC 或安慰剂的冠状动脉内输注。比较 CDC 组和安慰剂组之间 MRI 测得的节段性心肌周向应变 (Ecc) 从基线到 6 个月的变化。结果 共有 124 名患者完成了 6 个月的随访（平均 (SD) 年龄 54.3 (10.8)，其中 108 名 (87.1%) 男性）。与安慰剂组患者（0.2%（3.7），p=0.05）相比，接受 CDC 治疗的患者（-0.5%（4.0））的节段 Ecc 改善显着更大。在含有疤痕组织的节段中观察到节段 Ecc 改善的最大益处（接受 CDC 的患者节段 Ecc 变化为 -0.7% (3.5)，而安慰剂组患者节段 Ecc 变化为 0.04% (3.7)，p=0.04）。结论 在 MI 后左心室功能障碍的患者中，CDC 给药可改善节段性心肌功能。我们的研究结果强调了节段心肌功能指数作为未来心肌梗死后患者临床试验终点的重要性。试用注册号[NCT01458405][1]。无可用数据。作者声明，其他研究人员将无法获得本手稿的支持数据。[1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01458405&atom=%2Fopenhrt%2F8%2F2%2Fe001614.atom