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

71 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 Jan 1

Fingerprint

Adult Stem Cells
Mesenchymal Stromal Cells
Multicenter Studies
Myocardial Infarction
Safety
Single-Photon Emission-Computed Tomography
Bone Marrow
Stroke Volume
Left Ventricular Function
Reperfusion
Therapeutics
Arteries
Control Groups

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

@article{940acd2f02c04d9fac84b84681cccf54,
title = "A randomized, open-label, multicenter trial for the safety and efficacy of adult mesenchymal stem cells after acute myocardial infarction",
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).",
author = "Lee, {Jun Won} and Lee, {Seung Hwan} and Youn, {Young Jin} and Ahn, {Min Soo} and Kim, {Jang Young} and Yoo, {Byung Su} and Junghan Yoon and Woocheol Kwon and Hong, {In Soo} and Kyounghoon Lee and Jun Kwan and Park, {Keum Soo} and Donghoon Choi and Jang, {Yang Soo} and Hong, {Mun K.}",
year = "2014",
month = "1",
day = "1",
doi = "10.3346/jkms.2014.29.1.23",
language = "English",
volume = "29",
pages = "23--31",
journal = "Journal of Korean Medical Science",
issn = "1011-8934",
publisher = "Korean Academy of Medical Science",
number = "1",

}

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

In: Journal of Korean medical science, Vol. 29, No. 1, 01.01.2014, p. 23-31.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A randomized, open-label, multicenter trial for the safety and efficacy of adult mesenchymal stem cells after acute myocardial infarction

AU - Lee, Jun Won

AU - Lee, Seung Hwan

AU - Youn, Young Jin

AU - Ahn, Min Soo

AU - Kim, Jang Young

AU - Yoo, Byung Su

AU - Yoon, Junghan

AU - Kwon, Woocheol

AU - Hong, In Soo

AU - Lee, Kyounghoon

AU - Kwan, Jun

AU - Park, Keum Soo

AU - Choi, Donghoon

AU - Jang, Yang Soo

AU - Hong, Mun K.

PY - 2014/1/1

Y1 - 2014/1/1

N2 - 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).

AB - 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).

UR - http://www.scopus.com/inward/record.url?scp=84907424372&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84907424372&partnerID=8YFLogxK

U2 - 10.3346/jkms.2014.29.1.23

DO - 10.3346/jkms.2014.29.1.23

M3 - Article

C2 - 24431901

AN - SCOPUS:84907424372

VL - 29

SP - 23

EP - 31

JO - Journal of Korean Medical Science

JF - Journal of Korean Medical Science

SN - 1011-8934

IS - 1

ER -