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Days after Harvard Medical School said it was extensive falsified or fabricated data from the laboratory of a prominent heart researcher, doctors and scientists are urging a halt to a medical trial based in part on his work. They say that sick people should not be subjected to the risks of an experiment whose underlying science has been called into question.
In the ongoing, taxpayer-funded trial, cardiac stem cells are injected into the hearts of people with heart failure, in the hopes that these cells – alone or in combination with others – will improve patients' heart function.
The regenerative effects of these cells were first reported by an influential but controversial scientist, Piero Anversa, whose work has been thrown into doubt. Harvard disclosed a year-long investigation in the field of 31 papers from his laboratory, which was identified. Last year, the Harvard-affiliated Brigham and Women's Hospital, where Antwerp worked until 2015, reached a $ 10 million settlement with the Department of Public Security, which had been used by Antwerpa's laboratory in grant applications for federal funding.
On Wednesday, the New England Journal of Medicine, the paper reads, "One of the most important things in the world." information on the two papers.
New York Medical College, where Antwerpa previously worked, released a statement saying that "serious concerns" have been raised about a 17-year-old study. It said an investigation has been initiated.
The trial is being conducted by the national clinical trial network, which is $ 63 million in federal funds. But let me say that it is easier to proceed and that it is easier to proceed. It requires an invasive biopsy that can cause serious complications.
One patient died after their heart was perforated during a biopsy.
"I think that the trial should be halted, and they should have an external review," said Darryl Davis, a cardiologist at the University of Ottawa's Heart Institute studying how to regenerate heart tissue. "The Antwerpa data is part of the rationale for that trial, and I think we have a better understanding of what these cells actually can do to patients than to have an invasive procedure."
Antwerpa's laboratory has been researched in the field of clinical trials and has been investigated. However, the National Heart, Lung and Blood Institute does not consider the trial of Antwerpa's work, according to Denis Buxton, director of the Basic and Early Translational Research program at the institute. Buxton said that the trial is instead based on an idea that grew out of Antwerp's original work – that the cells secrete various molecules that help regenerate muscle tissue, though he said it was "not a well-characterized effect at the moment."
"Multiple preclinical studies have been demonstrated in cardiac function, and advanced heart failure patients really have no treatment options and have poor survival," Buxton said. There is a need for new therapies that can improve the quality of life in these patients. I think the feeling is this trial has the potential to provide such an option. "
He said that it would be a good idea to have patient feedback in this area, and that patients would be informed of the board's recommendations.
Antwerpa's lawyer said his client by the scientific findings in his papers and that Antwerpa only learned from the Harvard investigation that has a longtime colleague who left his lab in 2013 had improperly altered images. Antwerpa says that, in many cases, those pictures, and the results will still stand, his lawyer said.
"There is nothing wrong with c-positive cardiac stem cells, and the trial will answer the questions about their efficacy in patients," Antwerpa said in an email.
Antwerpa's work to promote prominence amid broad enthusiasm about stem cells in the early 2000s. Cells and their patients have been able to provide relief to the heart, or to help patients recover from heart failure.
The discovery quickly led to clinical trials. The current trial, called CONCERT-HF, is based on an earlier clinical trial in which Antwerp has developed c-kit cells to be infused into patients' hearts. The report of results from this trial is now overshadowed by questions about the integrity of images of the stem cells that were created and characterized in Antwerp, where they were put into patients.
Roberto Bolli, the University of Louisville, a cardiologist who led the trial, told The Washington Post that the work of his team did not have anything to do with cell manufacturing in Boston. He said he did not have enough information about the problems in Antwerp.
"This is obviously a major concern, and we are trying to clarify this important issue," Bolli said.
The National Heart, Lung and Blood Institute said that it was not possible to find an explanation for how c-kit cells work, but that they were not affiliated with Antwerp. heart muscle, and instead were dying or fusing with other cells. To explain the effects the cells had on heart function in animal studies c-kit cells themselves do not regenerate, but secrete various substances, exerting what are called "paracrine effects."
Anversa told the Post that the CONCERT trial is based on his work said in a phone interview, "I'm not sure I really understand why the trial should be stopped."
In the trial CONCERT, cells are harvested from the heart and bone marrow of patients. Two types of stem cells are produced in the body of patients with different types of cells, such as bone marrow-derived cells, or both. The patient died after a biopsy of the person's heart cells and before the stem cells were implanted.
"I do think it's time to pause and evaluate things like the CONCERT trial," said Deepak Srivastava, president of the Gladstone Institutes and president-elect of the International Society for Stem Cell Research. "And if there is not a foundation for that, I think in most fields, most such trials would be halted."
Elizabeth McNally, a cardiologist and director of the Center for Genetic Medicine at Northwestern University's Feinberg School of Medicine, said that, years ago, she was excited by the findings of Antwerpa's lab, but then had trouble replicating them herself. It has been described as "religious fervor" that has taken hold of those who have believed that they have been able to regenerate the disease.
"It's disappointing that it took so many years for this to come out," McNally said. "It's a question that the trial should be still ongoing, and I think it should be more important than that."
Charles Murry, director of the Institute for Stem Cell and Regenerative Medicine at the University of Washington, on the subject of the safety of patients in the trial.
"Murry, that the scientific premise of this trial is not longer valid," Murry said. "If I was leading this trial, I think I would have it based on these recent developments."
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