This news release positively spins a study in which researchers observed physical changes in old rats that were injected with cardiac stem cells from newborn rats. Publishing in the European Heart Journal, researchers concluded that cells from baby rats appeared to “rejuvenate” aged rats compared with a placebo. The news release brazenly speculates about potential benefits for humans without cautioning that findings from a rat study can’t be extrapolated to people. It also omits potential harms and costs.
To its credit, the release discloses the fact that Cedars-Sinai and a lead researcher have a financial interest in Capricor Therapeutics, which holds the license for the cardiac stem cell product, known as CAP-1002. It also acknowledges that the study didn’t examine an outcome that the rats — and some humans — would really care about: whether stem cells extend their lifespans.
Heart failure is a progressive disease that affects millions of Americans. Although therapies exist to reduce symptoms, at least in those suffering from systolic dysfunction, there are no curative treatments. Stem cell therapies have been explored as possible options over the years with mixed results.
Exuberant news releases about stem cell therapies can spark news coverage that attracts investors and fuels enthusiasm for more research. In this case, it seems Capricor Therapeutics could use some positive news. In recent months, it lost key investor Johnson & Johnson after disclosing that a phase 2 clinical trial of its chief product was failing to show efficacy in heart attack patients.
Larry Husten wrote in MedPage Today that Capricor researchers had difficulty acknowledging that the therapy didn’t work: “Stem cells have never been shown to have any clinical benefit in patients with heart disease. But there is mounting anecdotal evidence that they may have serious adverse effects on the reasoning and objectivity of the medical researchers, biotechnology executives and investors who get sucked into their orbit.” Journalists, too, need to resist that gravitational pull. In this instance, at least one news outlet did not. CNN ran this glowing story: “‘Unexpected fountain of youth’ found in cardiac stem cells, says researcher.”
There’s no discussion of the potential cost of stem cell infusions generally or of CAP-1002.
The news release says rats injected with stem cells:
It gives no numbers to give readers an idea of how large these benefits were. It doesn’t tell us how many animals were involved in the study and what the comparator was (baseline vs. placebo treated) for the benefits mentioned. Of course, such data isn’t indicative of what might happen in humans, but if it’s worth reporting an outcome, the numbers should be included.
Potential harms of stem cell therapy are not mentioned, and it’s impossible to know for sure what the risks of this intervention might be. Safety data appears to be limited. The published study states that cardiosphere-derived cells “are already in advanced clinical testing and have proven safe to date,” but it cites just one article that was written by one of the same researchers, Eduardo Marban, who developed and owns a financial interest in the technology.
To be clear, the study was conducted in a total of 23 rats, 10 of which received the stem cell therapy. The news release acknowledges some limitations of the study:
“This study didn’t measure whether receiving the cardiosphere-derived cells extended lifespans, so we have a lot more work to do,” said Lilian Grigorian-Shamagian, MD, PhD, co-primary investigator and the first author of the study. “We have much to study, including whether CDCs need to come from a young donor to have the same rejuvenating effects and whether the extracellular vesicles are able to reproduce all the rejuvenating effects we detect with CDCs.”
But it omits the most important limitation: data from rats can’t be extrapolated to humans.
The news release states that “general support” for Marban’s lab is provided by the National Institutes of Health, and that Cedars-Sinai along with its heart institute chief Eduardo Marban, a co-author of the study, have financial interests in Capricor, which own the process to grow cardiac-derived stem cells.
Who’s to say that lifestyle factors such as a good diet and robust exercise wouldn’t do a good job of staving off the harms of aging more reliably than a costly stem cell procedure? That’s not mentioned.
This was a close call. We rate this criterion Satisfactory since the release includes some cautionary language about the availability and applicability of cardiac stem cells, stating that they “could someday help reverse the aging process in the human heart” and “We have much to study…”
However, the release also mentions that the cardiac cells “have been used in other human clinical trials,” but doesn’t clarify whether it’s been approved by the FDA for use in humans.
There’s no attempt to put this study in the context of numerous stem cell studies that have been performed in recent years. Many studies have attempted to show that stem cells can be used to improve heart function or slow the aging process, including a recent study that concluded stem cells in the hypothalamus control aging.
The news release repeatedly uses speculative language:
Of course while stem cells could do all of these things, they also could not do them.
Also egregious is a premature statement from lead researcher Eduardo Marban, who is married to the CEO of the company that makes the cells:
“The way the cells work to reverse aging is fascinating,” Marban said. “They secrete tiny vesicles that are chock-full of signaling molecules such as RNA and proteins. The vesicles from young cells appear to contain all the needed instructions to turn back the clock.”
Systematic, Criteria-Driven
Monday at #ADA2021, an infectious disease epidemiologist, a journalist, and a researcher shared perspectives on communication of risk in the era of COVID-19: http://ow.ly/ROfR30rMeE7 @AstleyCM @garyschwitzer @berthahidalgo @ADA_DiabetesPro
Shoutouts to @susan_bewley @drkevinknopf @MichaelBaum11 in this call for more than fawning coverage from press releases for these kinds of stories.
Also, linked history inside goes back 5 years just on Grail apparently trying to become Holy Grail. https://twitter.com/garyschwitzer/status/1408849696416841731
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