Government health officials stopped a clinical trial Oct. 29, which tested stem cell therapy on heart failure patients, due to recommendations that 31 articles related to the test be retracted, according to STAT.
"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," the National Heart, Lung and Blood Institute issued in a statement Oct. 29.
The New England Journal of Medicine retracted a paper related to the trial Oct. 17 due to concern about other papers written by Piero Anversa, MD, a stem cell researcher. On Oct. 3, both Boston-based Harvard Medical School and Brigham and Women's Hospital recommended 31 papers written by Dr. Anversa be retracted from their publications.
David Goff, MD, PhD, director of the Division of Cardiovascular Sciences at NHLBI, confirmed the clinical trial known as CONCERT-HF was paused.
Dr. Anversa's research hypothesized the human heart has stem cells, called c-kit cells, which can regenerate cardiac muscle after a heart attack. Researchers have failed to replicate his findings.
The CONCERT-HF study tried to determine whether the c-kit cells worked alone or with other stem cells after chronic heart failure. Dr. Goff indicated the study was approved in 2015 and based off 11 reports from eight different labs, none of which were Dr. Anversa's.
The study was conducted on 125 patients, 117 of which had bone marrow or heart tissue collected. Ninety have been treated. All of the participants are in the process of being notified about the clinical trial's delay.
Dr. Goff told STAT NHLBI has requested the board completed an "expeditious review in keeping with appropriate rigor." He added, "We have a responsibility to our participants and to generating knowledge to improve the health of people with heart failure."
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