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A Phase 2 trial of cell therapy for patients with heart failure and reduced ejection fraction suspended registration following a scandal that led to at least one newspaper article withdrawal and many others.
The National Heart, Lung and Blood Institute (NHLBI) is pausing the CONCERT-HF trial (combination of mesenchymal stem cells and cardiac C-kit +) as a regenerative therapy for heart failure (CONCERT- HF) comparing the two cell therapies, alone or together. a placebo control, the institute announced today.
The Data Monitoring and Safety Committee has recommended its suspension on Oct. 25 "to be cautious in order to ensure that the study continues to meet the highest standards in terms of participant safety and scientific integrity, "said the NHLBI, adding that no known safety issues had arisen.
The purpose of the trial was to randomize patients with ischemic myocardial injury and NYHA class 1 to 3 heart failure with a LVEF of 40% or less in one of four groups, all blind; he had a target population of 144.
the New England Journal of Medicine recently retracted a publication and expressed concern over two more on the work led by Piero Anversa, MD, a former professor of the Harvard Medical School, who had left the institution after being suspected that he was not working. much of his published data had been manipulated or fraudulent.
As recently reported by theheart.org | Medscape Cardiology, the retraction closely follows the recommendations of Harvard and the affiliate Brigham & Women's Hospital that 31 publications from Antwerp be retracted as they are based on fabricated or falsified data.
"NHLBI will honor its commitment to CONCERT-HF participants and will continue the follow-up protocol during this break for all participants who have already been treated in the study," said the institute.
Statement on NHLBI's decision to suspend the CONCERT-HF trial. Published October 29, 2018.
Follow Steve Stiles on Twitter: @ SteveStiles2. For more information on theheart.org, follow us on Twitter and Facebook.
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