心脏干细胞移植治疗缺血性心肌病患者的研究（SCIPIO 试验）：外科手术相关问题及磁共振评估心肌功能和存活的中期分析。
Administration of cardiac stem cells in patients with ischemic cardiomyopathy: the SCIPIO trial: surgical aspects and interim analysis of myocardial function and viability by magnetic resonance.
机构信息
Division of Cardiovascular Medicine, University of Louisville, Louisville, KY, USA.
出版信息
Circulation. 2012 Sep 11;126(11 Suppl 1):S54-64. doi: 10.1161/CIRCULATIONAHA.112.092627.
BACKGROUND
SCIPIO is a first-in-human, phase 1, randomized, open-label trial of autologous c-kit(+) cardiac stem cells (CSCs) in patients with heart failure of ischemic etiology undergoing coronary artery bypass grafting (CABG). In the present study, we report the surgical aspects and interim cardiac magnetic resonance (CMR) results.
METHODS AND RESULTS
A total of 33 patients (20 CSC-treated and 13 control subjects) met final eligibility criteria and were enrolled in SCIPIO. CSCs were isolated from the right atrial appendage harvested and processed during surgery. Harvesting did not affect cardiopulmonary bypass, cross-clamp, or surgical times. In CSC-treated patients, CMR showed a marked increase in both LVEF (from 27.5 ± 1.6% to 35.1 ± 2.4% [P=0.004, n=8] and 41.2 ± 4.5% [P=0.013, n=5] at 4 and 12 months after CSC infusion, respectively) and regional EF in the CSC-infused territory. Infarct size (late gadolinium enhancement) decreased after CSC infusion (by manual delineation: -6.9 ± 1.5 g [-22.7%] at 4 months [P=0.002, n=9] and -9.8 ± 3.5 g [-30.2%] at 12 months [P=0.039, n=6]). LV nonviable mass decreased even more (-11.9 ± 2.5 g [-49.7%] at 4 months [P=0.001] and -14.7 ± 3.9 g [-58.6%] at 12 months [P=0.013]), whereas LV viable mass increased (+11.6 ± 5.1 g at 4 months after CSC infusion [P=0.055] and +31.5 ± 11.0 g at 12 months [P=0.035]).
CONCLUSIONS
Isolation of CSCs from cardiac tissue obtained in the operating room is feasible and does not alter practices during CABG surgery. CMR shows that CSC infusion produces a striking improvement in both global and regional LV function, a reduction in infarct size, and an increase in viable tissue that persist at least 1 year and are consistent with cardiac regeneration.
CLINICAL TRIAL REGISTRATION
This study is registered with clinicaltrials.gov, trial number NCT00474461.
背景
SCIPIO 是一项针对缺血性病因心力衰竭患者的首次人体、1 期、随机、开放标签的自体 c-kit(+)心脏干细胞 (CSC) 试验，这些患者正在接受冠状动脉旁路移植术 (CABG)。在本研究中，我们报告了手术方面和中期心脏磁共振 (CMR) 结果。
方法和结果
共有 33 名患者（20 名 CSC 治疗组和 13 名对照组）符合最终入选标准并被纳入 SCIPIO。CSC 是从手术中采集和处理的右心房附件中分离出来的。采集过程不会影响心肺旁路、体外循环或手术时间。在 CSC 治疗组患者中，CMR 显示 LVEF 明显增加（从 27.5 ± 1.6%到 35.1 ± 2.4%[P=0.004，n=8]和 41.2 ± 4.5%[P=0.013，n=5]，分别在 CSC 输注后 4 个月和 12 个月）和 CSC 输注区域的局部 EF。CSC 输注后梗死面积（晚期钆增强）减小（通过手动描绘：4 个月时为-6.9 ± 1.5 g[-22.7%] [P=0.002，n=9]，12 个月时为-9.8 ± 3.5 g[-30.2%] [P=0.039，n=6]）。LV 无活力质量甚至减少更多（4 个月时为-11.9 ± 2.5 g[-49.7%] [P=0.001]，12 个月时为-14.7 ± 3.9 g[-58.6%] [P=0.013]），而 LV 有活力质量增加（CSC 输注后 4 个月时为+11.6 ± 5.1 g [P=0.055]，12 个月时为+31.5 ± 11.0 g [P=0.035]）。
结论
从手术室获得的心脏组织中分离 CSC 是可行的，并且不会改变 CABG 手术期间的操作。CMR 显示，CSC 输注可显著改善整体和局部 LV 功能，减少梗死面积，并增加有活力的组织，这些改善至少持续 1 年，并与心脏再生一致。
临床试验注册
该研究在 clinicaltrials.gov 上注册，注册号为 NCT00474461。
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