Evidence map›Paper›PMID 24431901›Full record

Trial reportJournal of Korean medical science2014

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 and 5 more

Registry-linked trialAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of Korean medical science, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01392105 (A Randomized, Open-label, Multicenter Trial for the Safety and Efficacy of Intracoronary Adult Human Mesenchymal Stem Cells After Acute Myocardial Infarction), which is not on this map. Cited by 99 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
99citing papers in PubMed, 14 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01392105 phase2 / phase3completednot on this map

A Randomized, Open-label, Multicenter Trial for the Safety and Efficacy of Intracoronary Adult Human Mesenchymal Stem Cells After Acute Myocardial Infarction

TypeinterventionalSponsorYonsei UniversityRan2007 to 2010Enrolled80ConditionsAcute Myocardial InfarctionArmsMesenchymal stem cell, Control group
3 · Its place in the literature

Who cites it

99 citing papers in PubMed, 14 syntheses or guidelines pooled it.

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  13. Stem cell treatment for acute myocardial infarction.The Cochrane database of systematic reviews · 2015
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39 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Jun-Won LeeDivision of Cardiology, Yonsei University Wonju College of Medicine, Wonju, Korea.
Seung-Hwan LeeDivision of Cardiology, Yonsei University Wonju College of Medicine, Wonju, Korea.
Young-Jin YounDivision of Cardiology, Yonsei University Wonju College of Medicine, Wonju, Korea.
Min-Soo AhnDivision of Cardiology, Yonsei University Wonju College of Medicine, Wonju, Korea.
Jang-Young KimDivision of Cardiology, Yonsei University Wonju College of Medicine, Wonju, Korea.
Byung-Su YooDivision of Cardiology, Yonsei University Wonju College of Medicine, Wonju, Korea.
Junghan YoonDivision of Cardiology, Yonsei University Wonju College of Medicine, Wonju, Korea.
Woocheol KwonDepartment of Radiology, Yonsei University Wonju College of Medicine, Wonju, Korea.
In-Soo HongDepartment of Radiology, Yonsei University Wonju College of Medicine, Wonju, Korea.
Kyounghoon LeeDepartment of Cardiology, Gachon Medical School, Gil Medical Center, Incheon, Korea.
Jun KwanDivision of Cardiology, Department of Internal Medicine, Inha University Hospital, Incheon, Korea.
Keum Soo ParkDivision of Cardiology, Department of Internal Medicine, Inha University Hospital, Incheon, Korea.
Donghoon ChoiYonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of Medicine, Seoul, Korea.
Yang Soo JangYonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of Medicine, Seoul, Korea.
Mun K HongDivision of Cardiology, Department of Medicine, St. Luke's Roosevelt Hospital, Columbia University College of Physicians and Surgeons, New York, NY, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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).

Indexed as

AdultAgedBone Marrow CellsCell- and Tissue-Based TherapyEchocardiographyFemaleHeartHumansMaleMesenchymal Stem CellsMesenchymal Stem Cell TransplantationMiddle AgedMyocardial InfarctionPilot ProjectsStroke VolumeTomography, Emission-Computed, Single-PhotonMesenchymal Stem CellsMyocardial InfarctionVentricular Dysfunction, Left

Identifiers

PMID24431901
PMCPMC3890472

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.