A randomized, open-label, multicenter trial for the safety and efficacy of adult mesenchymal stem cells after acute myocardial infarction.
A randomized, open-label, multicenter trial for the safety and efficacy of adult mesenchymal stem cells after acute myocardial infarction.
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DOI：
10.3346/jkms.2014.29.1.23
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发表时间：
2014-01
影响因子：
4.5
通讯作者：
Hong MK
中科院分区：
文献类型：
--
作者：
Lee JW;Lee SH;Youn YJ;Ahn MS;Kim JY;Yoo BS;Yoon J;Kwon W;Hong IS;Lee K;Kwan J;Park KS;Choi D;Jang YS;Hong MK
最近的研究表明，冠状动脉内注射骨髓间充质干细胞(MSCs)可以改善急性心肌梗死(AMI)患者的左心功能。然而，骨髓间充质干细胞在急性心肌梗死中的安全性和有效性仍存在争议。因此，我们进行了一项随机先导研究，以调查骨髓间充质干细胞在急性心肌梗死患者中的安全性和有效性。80例再通治疗成功的急性心肌梗死患者被随机分配，在1个月时接受冠状动脉内注射自体骨髓来源的MSCs至梗塞相关动脉。在随访期内，58名患者完成了试验。主要终点是6个月时单光子发射计算机断层扫描(SPECT)测定的左心室射血分数(LVEF)的变化。我们还评估了与治疗相关的不良事件。骨髓间充质干细胞移植组移植后6个月左心室射血分数的绝对改善率为5.9%±8.5%，明显高于对照组的1.6%±7.0%(P=0.037)。冠状动脉内注射间充质干细胞期间未发现与治疗相关的毒性反应。随访期间未发生明显的心血管不良事件。综上所述，1个月时冠状动脉内输注人骨髓间充质干细胞是安全和耐受的，SPECT随访6个月后左心室射血分数略有改善。(ClinicalTrials.gov注册号：NCT01392105)
Recent studies suggest that the intracoronary administration of bone marrow (BM)-derived mesenchymal stem cells (MSCs) may improve left ventricular function in patients with acute myocardial infarction (AMI). However, there is still argumentative for the safety and efficacy of MSCs in the AMI setting. We thus performed a randomized pilot study to investigate the safety and efficacy of MSCs in patients with AMI. Eighty patients with AMI after successful reperfusion therapy were randomly assigned and received an intracoronary administration of autologous BM-derived MSCs into the infarct related artery at 1 month. During follow-up period, 58 patients completed the trial. The primary endpoint was changes in left ventricular ejection fraction (LVEF) by single-photon emission computed tomography (SPECT) at 6 month. We also evaluated treatment-related adverse events. The absolute improvement in the LVEF by SPECT at 6 month was greater in the BM-derived MSCs group than in the control group (5.9%±8.5% vs 1.6%±7.0%; P=0.037). There was no treatment-related toxicity during intracoronary administration of MSCs. No significant adverse cardiovascular events occurred during follow-up. In conclusion, the intracoronary infusion of human BM-derived MSCs at 1 month is tolerable and safe with modest improvement in LVEF at 6-month follow-up by SPECT. (ClinicalTrials.gov registration number: NCT01392105)