The CONCERT-HF trial is on "" pending a review by its data safety monitoring board of just how much of the rationale has been undermined by falsified and fabricated data.
An announcement Monday from the National Heart Lung and Blood Institute (NHLBI) sponsoring the trial said it "convened CONCERT-HF's Data and Safety Monitoring Board (DSMB) out of an abundance of caution to ensure the study continues to meet the highest standards for participant safety and scientific integrity," although there were no specific participant safety concerns.
Allegations of research misconduct against influential stem cell researcher Piero Anversa, MD, and the laboratory he directed until 2015 at Harvard-affiliated Brigham and Women's Hospital in Boston, date back at least to 2014 regarding data from as early as 2001. Some allegations were settled last year with the Justice Department.
Earlier this month, Harvard and the Brigham on stem cell research out of Anversa's lab. The New England Journal of Medicine quickly one it had published and two others with an "expression of concern."
While the questioned data have dealt with a wide range of stem cell types, and Anversa wasn't directly involved in CONCERT-HF, a group of outside researchers called for a halt to CONCERT-HF because Anversa's laboratory did the foundational work providing part of the rationale for it.
The Washington Post that the NHLBI didn't consider the trial to be based on Anversa's work, but to be based on an idea that grew out of it. Anversa's group originally found that c-kit heart cells could give rise to heart muscle, although many now believe such stem cells secrete substances that have that effect rather than regenerating muscle themselves.
The is testing c-kit+ cells alone, or in combination with mesenchymal stem cells from bone marrow, for a planned 144 patients with chronic heart failure with reduced ejection fraction from ischemic causes.
Follow-up of patients already treated in the trial will continue per protocol.