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Heart stem cell trial 'paused' in wake of study retraction

5 November 2018
Appeared in BioNews 974

A US government agency has 'paused' a trial of stem cell treatment for heart failure following calls for 31 scientific papers to be retracted.

'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).

A study in the New England Journal of Medicine was subsequently retracted, with the journal publishing an 'expression of concern' over two other papers from groups led by Dr Anversa. 

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.'

Heart Cell Therapy Trial Paused After Fraud Allegations
The Scientist |  30 October 2018
Heart failure study paused over concerns about disputed cell therapy papers
STAT |  29 October 2018
He Promised to Restore Damaged Hearts. Harvard Says His Lab Fabricated Research.
New York Times |  29 October 2018
Statement on NHLBI decision to pause the CONCERT-HF trial
US National Heart, Lung and Blood Institute |  29 October 2018
2 December 2019 - by Dr Rosie Morley 
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18 March 2019 - by Caroline Casey 
The Lancet has retracted a 2011 paper reporting clinical trial data using cardiac stem cells isolated by Dr Piero Anversa's former laboratory...
22 October 2018 - by Ruth Retassie 
Clinicians and researchers have petitioned that a clinical trial for a stem-cell based treatment for heart disease be halted, as some of the results on which it was based have been called into question...
25 June 2018 - by Dr Melanie Krause 
For the first time, scientists from Stanford University, California, have combined CRISPR genome editing with a stem cell system to model how a genetic mutation might affect heart disease risk...
26 May 2015 - by Paul Waldron 
A particular type of stem cell found in the heart can repair damage caused by heart attacks in mice, according to research...
25 March 2004 - by BioNews 
Two new studies have cast further doubt on the ability of blood stem cells to turn into heart cells, even though several clinical trials based on this promising new treatment are currently underway. Researchers at Stanford University, California, and the University of Washington in Seattle have failed to duplicate the...
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Two teams of scientists have made independent breakthroughs using stem cells to repair cardiac muscles damaged by heart attacks. They have shown in experiments on mice that heart muscle can repair after injections of stem cells. The stem cells used in the experiments were derived from the bone marrow of...
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