J Korean Med Sci.  2014 Jan;29(1):23-31. 10.3346/jkms.2014.29.1.23.

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

• 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

• KMID: 1796910
• DOI: http://doi.org/10.3346/jkms.2014.29.1.23

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)

Keyword

Mesenchymal Stem Cells; Myocardial Infarction; Ventricular Dysfunction, Left

MeSH Terms

Adult
Aged
Bone Marrow Cells/cytology
Cell- and Tissue-Based Therapy/*adverse effects
Echocardiography
Female
Heart/physiopathology
Humans
Male
Mesenchymal Stem Cell Transplantation/*adverse effects
Mesenchymal Stromal Cells/*cytology
Middle Aged
Myocardial Infarction/*therapy
Pilot Projects
Stroke Volume
Tomography, Emission-Computed, Single-Photon
Transplantation, Autologous
Treatment Outcome
Ventricular Function, Left
Young Adult

Figure

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  Fig. 1 Study design.

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  Fig. 2 Impact of MSCs treatment on LVEF by SPECT. MSCs, mesenchymal stem cells; LVEF, left ventricular ejection fraction; SPECT, single-photon emission computed tomography.

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