'Recent calls for the retraction of journal articles in related fields of cell therapy research have raised concerns about the scientific foundations of this trial,' said the National Heart, Lung and Blood Institute (NHLBI), which is part of the USA's National Institutes of Health.
The agency announced the suspension of the CONCERT-HF trial last week after Harvard Medical School and Brigham and Women's Hospital in Boston, Massachusetts, called for the papers by Dr Piero Anversa and his teams to be retracted amid allegations of falsified data (see BioNews 972).
The CONCERT-HF trial is examining the safety and effectiveness of using a type of heart stem cell called c-kit+ cells, either alone or with mesenchymal stem cells from bone marrow, in patients with chronic heart failure.
Dr Anversa, who was formerly employed by Harvard Medical School and Brigham and Women's Hospital, was once hailed as a pioneer of cardiac stem cell research. Dr Anversa advanced the idea that the heart contained stem cells, which could regenerate heart muscle after a heart attack.
However, there had been issues over years when other groups failed to replicate some of Dr Anversa's results (see BioNews 251).
The CONCERT-HF trial is sponsored by NHBLI and the University of Texas. Dr Lem Moye, a biostatistician at the university, told STAT that the researchers had contacted trial patients about the pause and clarified that this is not directly related to the controversial work.
'Although we do not follow the protocols of Dr Anversa… NHLBI would like to assure itself that our lab is in fact generating c-kit+ cells,' Moye told STAT. 'We hope that this will not take long.'