'Something Off About Recent Heart Failure Stem Cell Trial, Major Journal Admits'

 The BMJ slapped an "expression of concern" on a much-publicized stem cell trial it published just 2 weeks ago.

A boxed warning now lies at the top of the phase III study, PREVENT-TAHA8, which had reported that an intracoronary infusion of umbilical cord mesenchymal stem cells brought down the risk of heart failure risk in people with ST segment elevation acute myocardial infarction and left ventricular ejection fraction <40%.

"The editors judge that the trial may have breached accepted practices and that the results may not be reliable," wrote the BMJ team on Wednesday.

"The BMJ was alerted to post-publication discussion raising concerns about a variety of issues; some issues were apparent from the data that support the paper, and are linked to from the article. Examples of the issues identified include 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," journal editors explained.

PREVENT-TAHA8 was said to have been conducted in Shiraz, Iran, where 136 people got the experimental injections (containing Wharton's jelly derived mesenchymal stem cells) and 260 were randomly assigned standard care alone from September 2021 to October 2024.

On the journal discussion forum PubPeer, however, the study was met with public comments that were rife with doubt and suggestions of data manipulation. Of note were suspicious patterns in the study dataset, such as line repeats and height and weight being suspiciously over-reported as multiples of 5 kg.

For now, the BMJ has made no mention of retraction but says a probe is underway.

"The BMJ's content integrity team will take up the concerns with the authors, and investigate fully -- involving institutions and regulatory authorities as necessary. The authors have informed the journal that an auditable replacement dataset has been prepared and will be made available to The BMJ."

https://www.medpagetoday.com/publichealthpolicy/stemcellresearch/118484