A Randomized, Open-Label, Multicenter Trial for the Safety and Efficacy of Adult Mesenchymal Stem Cells after Acute Myocardial Infarction.
10.3346/jkms.2014.29.1.23
- Author:
Jun Won LEE
1
;
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
Author Information
1. Division of Cardiology, Yonsei University Wonju College of Medicine, Wonju, Korea. carshlee@yonsei.ac.kr
- Publication Type:Original Article ; Clinical Trial, Phase II ; Clinical Trial, Phase III ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
- Keywords:
Mesenchymal Stem Cells;
Myocardial Infarction;
Ventricular Dysfunction, Left
- MeSH:
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
- From:Journal of Korean Medical Science
2014;29(1):23-31
- CountryRepublic of Korea
- Language:English
-
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)
