Déjà Vu All Over Again? Results of Intracoronary Stem Cell Study Questioned

The BMJ has issued an expression of concern over a recent study on intracoronary infusion of stem cells after PCI, citing various problems raised after its publication in the journal.

“The editors judge that the trial may have breached accepted practices and that the results may not be reliable,” the BMJ statement says.

The PREVENT-TAHA8 study, as reported by TCTMD last month, found that an infusion of mesenchymal cells derived from Wharton’s jelly—the mucous connective tissue of the umbilical cord rich in stem cells—lowered the incidence of both HF and readmission to the hospital for HF at 3 years compared with standard care.

In their statement, BMJ editors list several potential issues with the study, including “irregularities in the data, concern about the inclusion of participants who did not meet the age criteria specified in the study, and concerns about undeclared conflicts of interest and authorship.”

The journal’s content integrity team is set to conduct a full investigation of the data, “involving institutions and regulatory authorities as necessary,” and will provide an update with their findings as well as any necessary changes, they say.

Armin Attar, MD, PhD (Shiraz University of Medical Sciences, Iran), who led PREVENT-TAHA8, did not respond to multiple requests for comment from TCTMD.

The expression of concern comes several years after a scandal rocked the field of cardiac stem cell research. A massive fraud perpetuated by one of the former giants in stem-cell research, Piero Anversa, MD, PhD, led to dozens of retractions from high-profile journals, among them Circulation and New England Journal of Medicine. Partners Healthcare and Brigham and Women’s Hospital, where Anversa had his lab, eventually paid the US government $10 million to settle allegations they fraudulently obtained funding from the National Institutes of Health.