Expression of concern: the SCIPIO trial

Abstract

On March 25, 2014, Gretchen Brodnicki, Harvard Medical School's Dean for Faculty and Research Integrity, wrote to The Lancet to inform us that “Harvard Medical School (HMS) and Brigham and Women's Hospital (BWH) are reviewing concerns about the integrity of certain data generated in a laboratory at BWH and included in the following published paper…[the] 2011 Lancet SCIPIO paper”. 1 Bolli R Chugh AR D'Amario D et al. Cardiac stem cells in patients with ischaemic cardiomyopathy (SCIPIO): initial results of a randomised phase 1 trial. Lancet. 2011; 378: 1847-1857 Summary Full Text PDF PubMed Scopus (1103) Google Scholar The focus of this investigation is on two supplemental figures published online (figures 2A and 3). As far as we are aware, the investigation is confined to the work completed at BWH. Gretchen Brodnicki continues, “Because review of this paper is ongoing, we cannot provide additional details at this time.” In further discussions with Harvard Medical School, we have been told that the current investigation into this aspect of the work reported in the SCIPIO trial is likely to take several months. As soon as The Lancet receives further information, we will inform readers accordingly. Cardiac stem cells in patients with ischaemic cardiomyopathy (SCIPIO): initial results of a randomised phase 1 trialThese initial results in patients are very encouraging. They suggest that intracoronary infusion of autologous CSCs is effective in improving LV systolic function and reducing infarct size in patients with heart failure after myocardial infarction, and warrant further, larger, phase 2 studies. Full-Text PDF