You may have read the commentary “Stem Cells Repair Injured Hearts” and then heard about the National Institutes of Health (NIH) decision to suspend a clinical trial using stem cells to treat heart failure due to oxygen deprivation, as occurs in a heart attack. The work highlighted in the commentary is by different authors and uses a different kind of stem cells and describes research performed in animal models.
The problematic research that resulted in the suspension of the clinical trial involves two kinds of stem cells: Those that can be obtained from a patient’s own bone marrow, which are called mesenchymal stem cells, and those obtained from the patient’s own heart, referred to as c-Kit-positive cardiac stem cells. At the core of the controversy are the c-Kit-positive cells. Many of the studies showing that c-Kit-positive cardiac stem cells represent a heart-regenerating cell population were published by Piero Anversa and his colleagues Annarosa Leri and Jan Kajstura. Those studies have come under serious criticism, with Harvard Medical School and Brigham and Women’s Hospital recommending that 31 papers be retracted. The issues raised involve scientific misconduct and data falsification.
On a scientific level, the question is whether c-Kit-positive cells in the heart really represent a true stem cell population that can self-renew and differentiate into new heart cells. Researchers have not been able to reproduce that finding. Instead, these cells may support heart repair through releasing signals to other cells in the heart. It is possible that the trial will continue after the Data and Safety Monitoring Board completes their review. However, it seems likely that the mechanism of any beneficial (or adverse) effects will not relate to any function of these c-Kit-positive cells as cardiac stem cells.
Commentary
N. R. Gough, Stem Cells Repair Injured Hearts. BioSerendipity (15 August 2018) https://www.bioserendipity.com/stem-cells-repair-injured-hearts/.
Clinical Trial
Combination of Mesenchymal and c-Kit+ Cardiac Stem Cells as Regenerative Therapy for Heart Failure (CONCERT-HF). https://clinicaltrials.gov/ct2/show/NCT02501811 (accessed 1 November 2018)
NIH Statement
Statement on NHLBI decision to pause the CONCERT-HF trial. https://www.nhlbi.nih.gov/news/2018/statement-nhlbi-decision-pause-concert-hf-trial (accessed 1 November 2018)
News Reports
I. Oransky, Harvard and the Brigham recommend 31 retractions for cardiac stem cell work. Retraction Watch (14 October 2018). https://retractionwatch.com/2018/10/14/harvard-and-the-brigham-recommend-31-retractions-for-cardiac-stem-cell-work/
C. Y. Johnson, Harvard investigation finds fraudulent data in papers by heart researcher. The Washington Post (15 October 2018). https://www.washingtonpost.com/science/2018/10/15/harvard-investigation-finds-fraudulent-data-papers-by-heart-researcher/
I. Oransky, A. Marcus, Harvard and the Brigham call for more than 30 retractions of cardiac stem cell research. STAT (14 October 2018). https://www.statnews.com/2018/10/14/harvard-brigham-retractions-stem-cell/
J. Kaiser, Federal officials pause trial testing stem cells for heart disease. Science (29 October 2018). https://www.sciencemag.org/news/2018/10/federal-officials-pause-trial-testing-stem-cells-heart-disease
Cite as: N. R. Gough, Scientific Misconduct Casts Doubt on Basis for a Stem Cell Clinical Trial. BioSerendipity (1 November 2018) https://www.bioserendipity.com/scientific-misconduct-casts-doubt-on-basis-for-a-stem-cell-clinical-trial/.