BioCentury
ARTICLE | Clinical News

NIH pauses stem cell trial after Brigham calls to retract 'fabricated' foundational research

November 2, 2018 7:52 PM UTC

NIH's National Heart, Lung, and Blood Institute (NHLBI) said Oct. 29 it will pause the Phase II CONCERT-HF trial testing a cardiac stem cell therapy as recent calls for retraction of journal articles in related research fields have "raised concerns about the scientific foundations of the trial." While none of the flagged articles "derive from the CONCERT-HF trial itself," NHLBI said it asked a DSMB to review the trial "out of an abundance of caution" to ensure patient safety and scientific integrity. The agency paused enrollment so that the DSMB may complete its review, but noted the board has not raised any participant safety concerns.

The halt comes two weeks after Harvard Medical School and Brigham and Women's Hospital recommended the retraction of 31 papers stemming from the former lab of Piero Anversa, which originated the theory that stem cells could be used to treat damaged heart tissue. The institutions said the 31 papers contained falsified and/or fabricated data, according to a joint statement to BioCentury on Oct. 15...