根据卫生署 105年国人十大死因统计资料显示，心脏疾病高居国人十大死因第二位，冠心病为其中最常见的一种。而缺血性心肌病(ischemic cardiomyopathy)是因为心肌的血液长期供应不足，导致心肌反复发生局部的坏死，也称心肌硬化，属于冠心病的一种。^1.2

美国的研究团队发表针对 65名缺血性心肌病患者进行自体干细胞治疗的临床试验结果报告，从结果中发现，使用间叶干细胞治疗的患者，可改善心脏衰竭指数，降低心肌梗塞百分比和改善心肌功能，证实了这种新治疗方法安全有效。³

Transendocardial Mesenchymal Stem Cells and Mononuclear Bone Marrow Cells for Ischemic Cardiomyopathy: The TAC-HFT Randomized Trial

Importance: Whether culture-expanded mesenchymal stem cells or whole bone marrow mononuclear cells are safe and effective in chronic ischemic cardiomyopathy is controversial.

Objective: To demonstrate the safety of transendocardial stem cell injection with autologous mesenchymal stem cells (MSCs) and bone marrow mononuclear cells (BMCs) in patients with ischemic cardiomyopathy.

Design, Setting, and Patients: A phase 1 and 2 randomized, blinded, placebo-controlled study involving 65 patients with ischemic cardiomyopathy and left ventricular (LV) ejection fraction less than 50% (September 1, 2009-July 12, 2013). The study compared injection of MSCs (n=19) with placebo (n = 11) and BMCs (n = 19) with placebo (n = 10), with 1 year of follow-up.

Interventions: Injections in 10 LV sites with an infusion catheter.

Main Outcomes and Measures: Treatment-emergent 30-day serious adverse event rate defined as a composite of death, myocardial infarction, stroke, hospitalization for worsening heart failure, perforation, tamponade, or sustained ventricular arrhythmias.

Results: No patient had a treatment-emergent serious adverse events at day 30. The 1-year incidence of serious adverse events was 31.6% (95% CI, 12.6% to 56.6%) for MSCs, 31.6% (95% CI, 12.6%-56.6%) for BMCs, and 38.1% (95% CI, 18.1%-61.6%) for placebo. Over 1 year, the Minnesota Living With Heart Failure score improved with MSCs (−6.3; 95% CI, −15.0 to 2.4; repeated measures of variance, P=.02) and with BMCs (−8.2; 95% CI, −17.4 to 0.97; P=.005) but not with placebo (0.4; 95% CI, −9.45 to 10.25; P=.38). The 6-minute walk distance increased with MSCs only (repeated measures model, P = .03). Infarct size as a percentage of LV mass was reduced by MSCs (−18.9%; 95% CI, −30.4 to −7.4; within-group, P = .004) but not by BMCs (−7.0%; 95% CI, −15.7% to 1.7%; within-group, P = .11) or placebo (−5.2%; 95% CI, −16.8% to 6.5%; within-group, P = .36). Regional myocardial function as peak Eulerian circumferential strain at the site of injection improved with MSCs (−4.9; 95% CI, −13.3 to 3.5; within-group repeated measures, P = .03) but not BMCs (−2.1; 95% CI, −5.5 to 1.3; P = .21) or placebo (−0.03; 95% CI, −1.9 to 1.9; P = .14). Left ventricular chamber volume and ejection fraction did not change.

Conclusions and Relevance: Transendocardial stem cell injection with MSCs or BMCs appeared to be safe for patients with chronic ischemic cardiomyopathy and LV dysfunction. Although the sample size and multiple comparisons preclude a definitive statement about safety and clinical effect, these results provide the basis for larger studies to provide definitive evidence about safety and to assess efficacy of this new therapeutic approach.

参考资料：

1. http://www.mohw.gov.tw/cp-16-33598-1.html

2. http://jibing.lookup.tw/39834.html#.Wa0l8rIjHIU

3. JAMA. 2014 Jan 1;311(1):62-73

编辑整理：干细胞论坛部落格