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NIH Stops Stem Cell Heart Failure Trial Over Retracted Data

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(dimitrisvetsikas1969, Pixabay)

30 Oct. 2018. National Heart, Lung, and Blood Institute, or NHLBI, part of the National Institutes of Health, is suspending a clinical trial of stem cells to regenerate new heart muscle. The mid-stage trial is based on preclinical research from a Harvard Medical School lab, which the university and one of its teaching hospitals now says may include falsified data.

Earlier in October, Harvard Medical School and Brigham and Women’s Hospital in Boston recommended retracting 31 studies authored by cardiologist Piero Anversa from scientific and medical journals that published his findings. As reported by the health news service STAT, the hospital agreed last year to a $10 million settlement with the U.S. government over claims that Anversa and colleagues fraudulently secured funding for their research. Anversa’s lab at Harvard closed in 2015.

The university and hospital told STAT and the web site Retraction Watch that “Following a review of research conducted in the former lab of Piero Anversa, we determined that 31 publications included falsified and/or fabricated data, and we have notified all relevant journals.” Retraction Watch reports that the journal Circulation in January 2014 retracted a study by Anversa and others published in 2012, indicating, “data are sufficiently compromised that a retraction is warranted.” And in April 2014 the journal The Lancet posted an Expression of Concern about the integrity of data from an early-stage clinical trial, published in 2011.

The current clinical trial is testing the ability of a form of cardiac stem cells known as c-kit+ to transform into healthy heart muscle in people with heart failure, a condition affecting some 5.7 million people in the U.S. Heart failure is a disorder where the heart cannot pump enough blood to meet the body’s needs, and occurs when the heart cannot fill with enough blood to pump, or heart muscle cannot exert enough force to pump blood to the rest of the body, or both conditions in some cases. The trial is assessing the safety, feasibility, and clinical outcomes of c-kit+ stem cells compared to and in combination with mesenchymal or adult stem cells from bone marrow, versus a placebo among 144 chronic heart failure patients.

NHLBI, a co-sponsor of the trial, says in a statement that the study’s data and safety monitoring committee recommends suspending the trial after “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.” While the committee says no safety concerns were expressed among individual patients in the trial, the board wants to pause the study and review the research, “out of an abundance of caution to ensure the study continues to meet the highest standards for participant safety and scientific integrity.”

The New York Times reports today that several independent studies failed to replicate Anversa’s findings. The Times quotes Anversa and frequent co-author Annarosa Leri that they “stand by the scientific findings in their papers, including the existence and potential therapeutic benefits of cardiac stem cells,” and blame a co-author for digitally manipulating images in the published studies to misrepresent the results.

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