The National Heart, Lung, and Blood Institute (NHLBI) of the US National Institutes of Health (NIH) has opted to pause the CONCERT-HF trial involving patients with chronic heart failure.
The decision is a result of recent calls for the withdrawal of journal articles in the fields of cell therapy research. The calls have also raised concerns about the scientific foundations of the CONCERT-HF trial.
Though the articles are not related to the Phase II trial, NHLBI intends to put the trial on hold to ensure the highest standards of safety for the participants and maintain scientific integrity.
Following the decision, CONCERT-HF’s Data and Safety Monitoring Board (DSMB) will be able to complete its review and will inform NHLBI’s future actions regarding the trial.
CONCERT-HF was designed to evaluate the feasibility, safety, and effect of autologous bone marrow-derived mesenchymal stem cells (MSCs) and c-kit+ cardiac stem cells (CSCs) both alone and in combination, compared to placebo (cell-free Plasmalyte-A medium), as well as each other, in subjects with heart failure of ischemic etiology.
The randomised, placebo-controlled, parallel assignment trial would have enrolled 144 participants.
The trial was designed to include a lead-in phase, with participants then been randomised in 1:1:1:1 ratio to receive the trial’s combination therapy, MSCs, CSCs, or placebo.
Investigators of the trial were planning to use an ‘intention-to-treat’ study population to conduct endpoint analysis and safety evaluations.
The primary endpoint of CONCERT-HF included changes in left ventricular ejection fraction (LVEF), in global strain (HARP MRI) and in regional strain (HARP MRI).