A Randomized, Open-Label, Multicenter Trial for the Safety and Efficacy of Adult Mesenchymal Stem Cells after Acute Myocardial Infarction

作者：Lee Jun Won; Lee Seung Hwan^*; Youn Young Jin; Ahn Min Soo; Kim Jang Young; Yoo Byung Su; Yoon Junghan; Kwon Woocheol; Hong In Soo; Lee Kyounghoon; Kwan Jun; Park Keum Soo; Choi Donghoon; Jang Yang Soo; Hong Mun K

来源：Journal of Korean Medical Science, 2014, 29(1): 23-31.

DOI：10.3346/jkms.2014.29.1.23

• Mesenchymal Stem Cells
• Myocardial Infarction
• Ventricular Dysfunction
• Left

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.

• 出版日期2014-1