NIH pauses $63M stem cell trial for heart failure amid controversy

The National Institutes of Health (NIH) is pausing a taxpayer-funded, $63 million trial of cardiac stems cells over questions about the basis for the research.

Cardiologists and researchers had previously called for the trial to be halted after an investigation by Harvard and Brigham and Women’s Hospital revealed 31 scientific studies authored by renowned stem cell pioneer Piero Anversa had been at least partially fabricated. Those organizations recommended the academic journals that published those studies retract them.

Anversa is not directly involved with the NIH study in question, but the stem cells he identified are being injected into the trial’s heart failure patients in an effort to repair damaged cardiac muscle. The trial has enrolled 125 of 144 patients, according to the Washington Post, and will now undergo a thorough review.

“Our commitment, first and foremost, is to patient safety,” David Goff, director of the Division of Cardiovascular Sciences at the National Heart, Lung and Blood Institute, told The Post. “We haven’t seen any safety signals related to the cell treatment, but we can’t do any of our research without the partnership of our participants, and we make a commitment to our participants that their safety is our highest priority.”

Goff noted the trial’s scientific basis is also supported by animal studies not conducted by Anversa, but said re-evaluating the study will “assure that it continues to meet the highest levels of adherence to participant safety and scientific integrity.”

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