Perin Emerson C, Sanz-Ruiz Ricardo, Sánchez Pedro L, Lasso José, Pérez-Cano Rosa, Alonso-Farto Juan C, Pérez-David Esther, Fernández-Santos Maria Eugenia, Serruys Patrick W, Duckers Henrick J, Kastrup Jens, Chamuleau Steven, Zheng Yi, Silva Guilherme V, Willerson James T, Fernández-Avilés Francisco
Stem Cell Center, Texas Heart Institute, Houston, TX.
Cardiology Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
Am Heart J. 2014 Jul;168(1):88-95.e2. doi: 10.1016/j.ahj.2014.03.022. Epub 2014 Apr 5.
Adipose-derived regenerative cells (ADRCs) can be isolated from liposuction aspirates and prepared as fresh cells for immediate administration in cell therapy. We performed the first randomized, placebo-controlled, double-blind trial to examine the safety and feasibility of the transendocardial injections of ADRCs in no-option patients with ischemic cardiomyopathy.
Procedural, postoperative, and follow-up safety end points were monitored up to 36 months. After baseline measurements, efficacy was assessed by echocardiography and single-photon emission computed tomography (6, 12, and 18 months), metabolic equivalents and maximal oxygen consumption (MVO2) (6 and 18 months), and cardiac magnetic resonance imaging (6 months). We enrolled 21 ADRC-treated and 6 control patients. Liposuction was well tolerated, ADRCs were successfully prepared, and transendocardial injections were feasible in all patients. No malignant arrhythmias were seen. Adverse events were similar between groups. Metabolic equivalents and MVO2 values were preserved over time in ADRC-treated patients but declined significantly in the control group. The difference in the change in MVO2 from baseline to 6 and 18 months was significantly better in ADRC-treated patients compared with controls. The ADRC-treated patients showed significant improvements in total left ventricular mass by magnetic resonance imaging and wall motion score index. Single-photon emission computed tomography results suggested a reduction in inducible ischemia in ADRC-treated patients up to 18 months.
Isolation and transendocardial injection of autologous ADRCs in no-option patients were safe and feasible. Our results suggest that ADRCs may preserve ventricular function, myocardial perfusion, and exercise capacity in these patients.
脂肪来源的再生细胞（ADRCs）可从抽脂吸出物中分离出来，并制备成新鲜细胞以便在细胞治疗中立即使用。我们进行了首例随机、安慰剂对照、双盲试验，以检验经心内膜注射ADRCs在无其他治疗选择的缺血性心肌病患者中的安全性和可行性。
对手术过程、术后及随访的安全性终点进行长达36个月的监测。在进行基线测量后，通过超声心动图和单光子发射计算机断层扫描（6、12和18个月时）、代谢当量和最大耗氧量（MVO2）（6和18个月时）以及心脏磁共振成像（6个月时）评估疗效。我们纳入了21例接受ADRCs治疗的患者和6例对照患者。抽脂耐受性良好，成功制备了ADRCs，且所有患者经心内膜注射均可行。未观察到恶性心律失常。两组不良事件相似。接受ADRCs治疗的患者代谢当量和MVO2值随时间保持稳定，但对照组显著下降。与对照组相比，接受ADRCs治疗的患者从基线到6个月和18个月时MVO2变化的差异显著更好。接受ADRCs治疗的患者通过磁共振成像显示左心室总质量和室壁运动评分指数有显著改善。单光子发射计算机断层扫描结果表明，接受ADRCs治疗的患者在长达18个月时可诱导缺血减少。
在无其他治疗选择的患者中分离并经心内膜注射自体ADRCs是安全可行的。我们的结果表明，ADRCs可能在这些患者中保留心室功能、心肌灌注和运动能力。
