A clinical trial assessing the use of stem cells to treat heart failure patients has been paused by the U.S. National Heart, Lung, and Blood Institute because it's based partly on what may be falsified or fabricated data from the laboratory of a Harvard Medical School-affiliated researcher.
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The $63-million CONCERT-HF trial will remain on hold while its data and safety monitoring board conducts a review to ensure the trial meets the "the highest standards for participant safety and scientific integrity," the NHLBI said Monday.
The patients in the study are being notified and the follow-up protocol of the trial will be continued for all patients who have already been treated.
The trial was launched to investigate whether a certain type of cardiac stem cell, either alone or in combination with other stem cells from the bone marrow, is safe and benefits patients with chronic heart failure, who have few treatment options.
Heart failure patients have a low quality of life and about half die within five years of diagnosis, according to NHLBI.
The clinical trial is based on research from a number of laboratories, including that of Harvard-affiliated Brigham and Women's Hospital heart researcher Piero Anversa. But the university recently announced that a years-long investigation discovered "falsified and/or fabricated data" in 31 papers from Anversa's laboratory, the Washington Post reported.
Anversa worked at the hospital until 2015. Last year, the hospital reached a $10 million settlement with the Justice Department to settle allegations that fake data was used by Anversa's laboratory in grant applications for federal funding.
Before working at Brigham and Women's Hospital, Anversa worked at New York Medical College. The college released a statement saying it launched an investigation after "serious concerns" had been raised about a 17-year-old study, the Post reported.
Last week, the New England Journal of Medicine retracted one Anversa laboratory paper and flagged two others with an "expression of concern," and is waiting for more information on those two papers.
Before the NHLBI announcement, scientists had called for the study to be stopped.
"I think that the trial should be halted, and they should have an external review," Darryl Davis, a cardiologist at the University of Ottawa Heart Institute studying how to regenerate heart tissue, told the Post.
"The Anversa data comprised part of the rationale for that trial, and I think we have to understand better what these cells actually can do before we subject the patients to the risk of having an invasive procedure," Davis said.
Anversa's lawyer said his client stands by his studies' findings and that Anversa only learned from the Harvard probe that a longtime colleague who left his lab in 2013 had improperly altered images, the Post reported.
In many cases, those images can be replaced with correct images, and the results will still be valid, according to Anversa, his lawyer said.
"There is nothing wrong with c-kit positive cardiac stem cells, and the trial will answer the questions concerning their efficacy in patients," Anversa said in an email, the Post reported.
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