A clinical trial testing whether cells described as cardiac stem cells could aid patients with chronic heart failure has been paused, according to a statement released yesterday (October 29) by the National Heart, Lung, and Blood Institute, which is collaborating with the University of Texas Health Science Center, Houston, on the experiment. The suspension of the study comes after Harvard Medical School and Brigham and Women’s Hospital recently recommended that 31 papers from the group that first reported these so-called c-kit cells be retracted.
In the early 2000s, cardiac researcher Piero Anversa claimed that c-kit cells could regenerate heart muscle, but those findings were controversial, and many other scientists failed to reproduce them. Nevertheless, clinical trials aiming to capitalize on the cells’ reported regenerative capacity commenced.
In 2015, the Combination of Mesenchymal and C-kit+ Cardiac Stem Cells as Regenerative Therapy for Heart Failure, or CONCERT-HF, trial began with the goal of enrolling 144 people. So far, it has enrolled 125, of which 117 have had heart and blood cells collected and 90 have been treated, according to Science.
One patient died during the harvest of heart cells, the Washington Post notes, “highlighting the inherent risks to vulnerable patients.”
As the trial proceeded, so did an investigation by Harvard and Brigham and Women’s into Anversa’s publications. It concluded that his papers include “falsified and/or fabricated data,” the two institutions told STAT and Retraction Watch earlier this month.
It’s because of this large batch of recommended retractions that CONCERT-HR is being put on hold, David Goff, director of the cardiovascular sciences division at the National Heart, Blood, and Lung Institute (NHBLI), tells STAT. Although none of the papers under suspicion specifically relate to the trial, the study’s Data and Safety Monitoring Board met last week at the request of NHBLI and recommended the suspension.
See “Hearts on Trial”
“I think it’s obviously the responsible thing to do, to pause and reevaluate the scientific basis for a clinical trial like this, and to really carefully ask the question—is there still a good scientific basis for it,” Richard Lee, a stem cell biologist at Harvard, tells the Post. “I won’t make that judgment, but I think it’s quite obvious, you can’t do trials on patients when there is a question about the basis."
The New York Times calls Anversa’s story a long fall from scientific grace with a hard landing, noting that not only did he present research that was later debunked, he was revered for that research. When the University of Washington’s Charles Murry disputed Anversa’s findings at a scientific meeting, saying that he had not been able to reproduce them and suggesting that Anversa’s images could have been manipulated, a colleague and collaborator of Anversa got up and told Murry that he wasn’t Plácido Domingo; that the reason Murry couldn’t reproduce Anversa’s results what he wasn’t enough of a virtuoso.
Anversa blames former lab member Jan Kajstura for the fraud and tells the Times that he knew nothing about it.
“This was a perfect storm of ego, wishful thinking and lack of accountability,” University of Arizona heart muscle researcher Jil Tardiff tells the Times.