Clinical Cardiovascular Cell Therapy, University of California, San Diego, La Jolla, California 92037-1300, USA.
JACC Cardiovasc Interv. 2009 Jan;2(1):9-16. doi: 10.1016/j.jcin.2008.11.003.
The aim of this study was to test safety and feasibility of myoblast transplantation with the Biosense-NOGA (Diamond Bar, California) 3-dimensional-guided endomyocardial delivery system.
Previous Phase-1 trials showed feasibility of epicardial injection of myoblasts. However, catheter-based delivery has several advantages: it can be applied on high-risk patients, the procedure can be repeated, and it is associated with less morbidity and mortality.
Twenty-three subjects, with previous myocardial infarction and heart failure, New York Heart Association (NYHA) functional class II to IV, were enrolled, 11 control and 12 treatment subjects. To assess safety, physical exam, electrocardiogram, continuous rhythm monitoring, quality of life assessments, and heart function were evaluated at baseline and follow-up until 1 year.
There was favorable safety: no difference between groups in arrhythmias, and no deaths. Treated subjects showed sustained improvements in NYHA and Minnesota Living with Heart Failure Questionnaire (MLHFQ) compared with control subjects (NYHA, -1.0 point in treatment vs. +0.3 point in control group, p < 0.0004; MLHFQ, -14 point in treatment vs. +1 point in the control group, p = 0.004). Blinded core laboratory echocardiography evaluations showed sustained reductions in the treatment versus control in end diastolic diameter (-0.03 cm vs. +0.05 cm, p = 0.07) and end systolic diameter (-0.05 cm vs. +0.1 cm, p = 0.07). Finally, NOGA voltage mapping demonstrated improved voltage measurements (+1.0 mV, p = 0.008).
This trial of myoblast transplantation via catheter into heart failure patients demonstrated safety and feasibility. Treated patients showed improvement in NYHA, MLHFQ, ventricular viability, and evidence of reverse ventricular remodeling. These data demonstrate positive safety outcomes and warrant initiation of larger phase 2, double-blind, placebo-controlled clinical trials.
本研究旨在测试使用 Biosense-NOGA（加利福尼亚州钻石吧）三维引导心肌内传递系统进行成肌细胞移植的安全性和可行性。
先前的 1 期试验已经证明了经心外膜注射成肌细胞的可行性。然而，基于导管的传递具有以下几个优势：它可以应用于高危患者，该程序可以重复进行，并且与较低的发病率和死亡率相关。
共纳入 23 名先前患有心肌梗死和心力衰竭、纽约心脏协会（NYHA）心功能 II 至 IV 级的患者，其中 11 名对照组患者和 12 名治疗组患者。为了评估安全性，在基线和随访 1 年时进行体格检查、心电图、连续节律监测、生活质量评估和心功能评估。
安全性良好：两组之间在心律失常方面没有差异，也没有死亡病例。与对照组相比，治疗组的 NYHA 和明尼苏达州心力衰竭生活质量问卷（MLHFQ）评分持续改善（NYHA，治疗组增加 1.0 分，对照组增加 0.3 分，p < 0.0004；MLHFQ，治疗组减少 14 分，对照组增加 1 分，p = 0.004）。盲法核心实验室超声心动图评估显示，与对照组相比，治疗组的舒张末期直径（-0.03cm 对+0.05cm，p = 0.07）和收缩末期直径（-0.05cm 对+0.1cm，p = 0.07）持续减少。最后，NOGA 电压图显示电压测量值改善（+1.0mV，p = 0.008）。
这项通过导管向心力衰竭患者进行成肌细胞移植的试验证明了其安全性和可行性。治疗组患者的 NYHA、MLHFQ、心室活力和逆向心室重构的证据均显示出改善。这些数据表明安全性结果良好，因此有必要开展更大规模的 2 期、双盲、安慰剂对照临床试验。
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