The idea of mesenchymal stromal/stem cells or MSCs for heart disease has been around a long time. It never seemed to make much sense to me though. The broader stem cells for heart disease sub-field of regenerative medicine also has had problems over the years.
A new BMJ paper reports a supposed major benefit of MSCs for patients after heart attacks. My first thought after looking at it was that the results seem way too good. And the changes too big.
The data suggest a huge reduction in risk of heart failure and other metrics.
My next thought, as in past years with other seemingly upbeat stem cell heart infusion reports, was to ask what the mechanism possibly could be? How could one transitory cardiac infusion of MSCs have such a big benefit? I don’t think it can.
Let’s look at this new paper and the controversy that quickly sprung up around it. The concerns raised about the data seem potentially quite serious. Some have even mentioned the possibility of retraction.
Before we get into that, a quick note that I have a new STAT News column that you might find worth a read: What will be born of the marriage of de-extinction firm Colossal and animal cloning biotech Viagen? I’ve written before about both Colossal Biosciences and Viagen. The two coming together opens up a greater chance of creating animals relatively closer to extinct ones, but true de-extinction is probably not possible any time soon.
Controversy over new MSCs for heart failure paper
The new umbilical cord MSCs for heart disease paper that just came out about a week ago already 30+ comments on PubPeer already including the first from Dorothy Bishop.
Here’s the article in BMJ: Prevention of acute myocardial infarction induced heart failure by intracoronary infusion of mesenchymal stem cells: phase 3 randomised clinical trial (PREVENT-TAHA8). The paper also got some upbeat press from New Scientist: Stem cell therapy lowers risk of heart failure after a heart attack.
The PubPeer comments note many odd things about the data. For instance, there are some suspicious repeating sets of the same values for different patients. Another commenter raised concerns about apparent undisclosed financial conflicts of interest.
These points along with the seemingly potentially too good to be right results and what I see as a highly questionable rationale for the study suggest more trouble ahead for this publication.
Note that the BMJ itself just published an investigation of dental stem cell banking, focusing on over-the-top marketing claims (including for heart disease) that are quite reminiscent of some umbilical cord cell banking marketing.
For more on this paper see Sleuths flag ‘complete mismatch’ in data of BMJ stem cell study from Retraction Watch.
Also, The Niche’s past coverage of the past Piero Anversa saga on stem cells for heart disease is worth a look for historical context.
More recommended reads
- FDA’s top drug regulator resigns amid investigation, STAT. This just adds to the chaos at the FDA. Tidmarsh resigned after it was revealed that there was a new investigation of him. Making it all the stranger, reportedly Tidmarsh in part thinks CBER Director Vinay Prasad may have had something to do with his troubles at the agency. You’ll recall that Prasad himself was ousted earlier this year before coming back.
- Google’s new h-index, Nature.
- ‘Biotech Barbie’ says the time has come to consider CRISPR babies. Do scientists agree? Nature. This piece on Cathy Tie is a solid article by Heidi Ledford. While it mentions the powerful, safe alternative of embryo screening for mutations, I would have liked to have seen more emphasis on how screening makes the idea of CRISPR’ing babies largely unnecessary. I’m not clear on why Tie seems to see herself as a “biotech Barbie” and what that means.
- Arizona AG sues umbilical cord blood registry over alleged scam, AZ Family. From the piece, “Arizona Attorney General Kris Mayes announced she is suing the private company Cord Blood Registry (CBR). CBR has a large storage facility in Tucson and she is calling it a scam.”