A phase 2 trial of cell therapy for patients with heart failure (HF) and reduced ejection fraction has suspended enrollment in the wake of an ongoing scandal that has led to at least one journal article retraction and calls for many others.
The National Heart, Lung, and Blood Institute (NHLBI) is "pausing" the Combination of Mesenchymal and C-kit+ Cardiac Stem Cells as Regenerative Therapy for Heart Failure (CONCERT-HF) trial comparing the two cell therapies, alone or together, with a placebo control, the institute announced today.
The trial's data and safety monitoring board recommended its suspension on October 25 "out of an abundance of caution to ensure the study continues to meet the highest standards for participant safety and scientific integrity," NHLBI said, adding that no known safety issues had arisen.
The trial had been randomizing patients with documentation of ischemic myocardial injury and NYHA class 1–3 heart failure with an LVEF of 40% or less to one of the four groups, all blinded; it had a target enrollment of 144.
The New England Journal of Medicine recently retracted a publication and issued an expression of concern about two others based on work led by Piero Anversa, MD, the former Harvard Medical School professor who left the institution amid suspicions that much of his published data had been manipulated or fraudulent.
As recently reported by theheart.org | Medscape Cardiology, the retraction closely followed recommendations from Harvard and the affiliated Brigham & Women's Hospital that 31 publications from Anversa be retracted because they are based on fabricated or falsified data.
"NHLBI will honor its commitment to CONCERT-HF participants and continue the follow-up protocol during this pause for all participants who have already been treated in the study," the institute said.
Statement on NHLBI decision to pause the CONCERT-HF trial. Published October 29, 2018.
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Cite this: Stem-Cell Therapy Trial in Heart Failure 'Paused' After NEJM Retraction - Medscape - Oct 29, 2018.