Editorial Expression of Concern: Implantation of a Novel Allogeneic Mesenchymal Precursor Cell Type in Patients with Isc
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EDITORIAL EXPRESSION OF CONCERN
Editorial Expression of Concern: Implantation of a Novel Allogeneic Mesenchymal Precursor Cell Type in Patients with Ischemic Cardiomyopathy Undergoing Coronary Artery Bypass Grafting: an Open Label Phase IIa Trial Kyriakos Anastasiadis 1 & Polychronis Antonitsis 1 & Stephen Westaby 2 & Ajan Reginald 3 & Sabena Sultan 2 & Argirios Doumas 4 & George Efthimiadis 5 & Martin John Evans 6
# Springer Science+Business Media, LLC, part of Springer Nature 2020
Correction to: J. of Cardiovasc. Trans. Res. https://doi.org/10.1007/s12265-016-9686-0 The Editor-in-Chief of the Journal of Cardiovascular Translational Research is issuing an Editorial Expression of Concern on this article [1]. Following an investigation into a number of concerns raised in relation to this article after publication, the journal has found that the study did not receive all necessary approvals from regulatory and ethical bodies. While it has been confirmed that the study received approval from both the AHEPA University Hospital IRB and the IRB of the School of Medicine, Aristotle University of Thessaloniki,
The online version of the original article can be found at https://doi.org/ 10.1007/s12265-016-9686-0 * Polychronis Antonitsis [email protected] 1
Cardiothoracic Department, AHEPA University Hospital, S. Kyriakidi 1, 546 36 Thessaloniki, Greece
2
The John Radcliffe Hospital, Oxford University Hospitals, Headington, Oxford, UK
3
Experimental Therapeutics, University of Oxford, Oxford, UK
4
Department of Nuclear Medicine, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece
5
First Cardiology Department, AHEPA University Hospital, Thessaloniki, Greece
6
School of Biosciences, Cardiff University, Wales, UK
our investigation has found that advance approvals were not obtained from the National Ethics Committee nor the National Organizations for Medicines, as required for clinical trials conducted in Greece. This Expression of Concern does not comment on whether the research followed applicable ethical standards. Additionally, during the investigation, the authors clarified the following about the methods: left ventricular ejection fraction (LVEF) at baseline was manually corrected by the independent referring cardiologists before inclusion in the study. After reviewing the raw data, discrepancies can be found between the estimated and calculated LVEF data. As this raises questions about the accuracy of the method to determine whether patients met the inclusion criterion of an LVEF of less than 40%, the readers are advised to interpret the findings related to the baseline LVEF data with caution. The authors would also like to correct the following details: Methods - culture of iMP The manuscript states that “the iMP cells used in this study were prepared under GMP/ISO 9001 conditions.” To avoid confusion, the authors would like to correct this to “the iMP cells used in the study were prepared under ISO 9001 and ISO 15189 conditions.” Authors’ Affiliations Dr Sabena Sultan, Aj
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