Authorities have ‘paused’ a trial investigating a new treatment for patients with chronic heart failure (CHF) amid concerns over the scientific foundations of the study.
Last week, the National Heart, Lung and Blood Institute (NHLBI) in the United States said it was suspending the CONCERT-HF trial which is investigating c-kit+ cells, either alone or in combination with bone marrow-derived mesenchymal stem cells, as a potential treatment for patients with CHF who have very limited treatment options.
In a statement, the NHLBI said recent calls for the retraction of journal articles in related fields of cell therapy research “had raised concerns about the scientific foundations of this trial”.
It stressed that while none of the articles in question derive from the CONCERT-HF trial itself, the trial’s Data and Safety Monitoring Board (DSMB) had decided to pause the trial to conduct a review. “The DSMB's review will be conducted as expeditiously as possible and will inform NHLBI’s future actions that will ensure the highest standards of participant safety and scientific integrity,” it said.
The NHLBI said it will continue the trial follow-up protocol during the pause for all participants who have already been treated as part of the study.