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).
authors.affiliation: Division of Cardiology, Yonsei University Wonju College of Medicine, Wonju, Korea.
authors.forename: Jun-Won
authors.initials: JW
authors.lastname: Lee
authors.affiliation: Division of Cardiology, Yonsei University Wonju College of Medicine, Wonju, Korea.
authors.forename: Seung-Hwan
authors.initials: SH
authors.lastname: Lee
authors.affiliation: Division of Cardiology, Yonsei University Wonju College of Medicine, Wonju, Korea.
authors.forename: Young-Jin
authors.initials: YJ
authors.lastname: Youn
authors.affiliation: Division of Cardiology, Yonsei University Wonju College of Medicine, Wonju, Korea.
authors.forename: Min-Soo
authors.initials: MS
authors.lastname: Ahn
authors.affiliation: Division of Cardiology, Yonsei University Wonju College of Medicine, Wonju, Korea.
authors.forename: Jang-Young
authors.initials: JY
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Yonsei University Wonju College of Medicine, Wonju, Korea.
authors.forename: Byung-Su
authors.initials: BS
authors.lastname: Yoo
authors.affiliation: Division of Cardiology, Yonsei University Wonju College of Medicine, Wonju, Korea.
authors.forename: Junghan
authors.initials: J
authors.lastname: Yoon
authors.affiliation: Department of Radiology, Yonsei University Wonju College of Medicine, Wonju, Korea.
authors.forename: Woocheol
authors.initials: W
authors.lastname: Kwon
authors.affiliation: Department of Radiology, Yonsei University Wonju College of Medicine, Wonju, Korea.
authors.forename: In-Soo
authors.initials: IS
authors.lastname: Hong
authors.affiliation: Department of Cardiology, Gachon Medical School, Gil Medical Center, Incheon, Korea.
authors.forename: Kyounghoon
authors.initials: K
authors.lastname: Lee
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Inha University Hospital, Incheon, Korea.
authors.forename: Jun
authors.initials: J
authors.lastname: Kwan
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Inha University Hospital, Incheon, Korea.
authors.forename: Keum Soo
authors.initials: KS
authors.lastname: Park
authors.affiliation: Yonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Donghoon
authors.initials: D
authors.lastname: Choi
authors.affiliation: Yonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Yang Soo
authors.initials: YS
authors.lastname: Jang
authors.affiliation: Division of Cardiology, Department of Medicine, St. Luke's Roosevelt Hospital, Columbia University College of Physicians and Surgeons, New York, NY, USA.
authors.forename: Mun K
authors.initials: MK
authors.lastname: Hong
mesh_terms: D000328:Adult; D000368:Aged; D001854:Bone Marrow Cells / Q000166:cytology; D064987:Cell- and Tissue-Based Therapy / Q000009:adverse effects*; D004452:Echocardiography; D005260:Female; D006321:Heart / Q000503:physiopathology; D006801:Humans; D008297:Male; D045164:Mesenchymal Stem Cell Transplantation / Q000009:adverse effects*; D059630:Mesenchymal Stem Cells / Q000166:cytology*; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy*; D010865:Pilot Projects; D013318:Stroke Volume; D015899:Tomography, Emission-Computed, Single-Photon; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D016277:Ventricular Function, Left; D055815:Young Adult
keywords: Mesenchymal Stem Cells; Myocardial Infarction; Ventricular Dysfunction, Left