A randomized, open-label, multicenter trial for the safety and efficacy of adult mesenchymal stem cells after acute myocardial infarction

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

Research output: Contribution to journalArticle

84 Citations (Scopus)

Abstract

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).

Original languageEnglish
Pages (from-to)23-31
Number of pages9
JournalJournal of Korean medical science
Volume29
Issue number1
DOIs
Publication statusPublished - 2014

All Science Journal Classification (ASJC) codes

  • Medicine(all)

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