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Stem cell ‘patch’ for heart failure: HealthDay cautions readers about small study size, lack of control group

Can Stem Cell 'Patch' Help Heart Failure?

Our Review Summary

ablation for atrial fibrillationThis story about a small-scale study placing stem cell “patches” onto the heart included important limitations, such as the small study design and lack of a control group.

But the story could have dug a little deeper on several fronts–heart surgery is not without risks, nor costs–but those points weren’t included.

 

Why This Matters

Preliminary studies involving small numbers of people need to be handled with care–you don’t want to create false hope in patients or exaggerate the findings. This story does a good job placing the research findings in context, in terms of both how far this work is removed from clinical relevance, and how the work fits into the broader field of stem cell therapeutics for heart disease.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

Costs aren’t addressed. This is a tricky one, given that this work is still so far removed from being used in clinical practice (and therefore having an established cost). However, stem cell therapies in general are notoriously expensive, so it’s certainly an issue worth noting. If it’s not too early to talk about benefits, it’s not too early to talk about costs.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The story doesn’t quantify benefits, instead using general language: “Over the next year, the patients generally showed small improvements in their symptoms — including the ability to walk without becoming breathless and fatigued.” How was that measured? And by how much did those measurements change?

That said, we’d really like to applaud the way that the story made clear the benefits couldn’t be explicitly tied to the stem cell treatment. We’ll talk about that a bit more under “Quality of Evidence.”

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

The story noted that the study was designed primarily to determine whether the technique was safe, and the researchers said it was. That’s consistent with the relevant paper, which reports that patients showed “no procedural-related complications.”

However, that does not mean the procedure is risk free and carries no harms. This is effectively heart surgery–what are the risks? That needed at least a passing mention.

Does the story seem to grasp the quality of the evidence?

Satisfactory

The story does a really good job here. For example, while the story offers only a vague description of the benefits, it makes very clear that the limitations of the study design make it impossible to tell whether the stem cell treatment actually contributed to any improvement in health. As the story notes, “it’s possible…the ‘modest’ symptom improvements would have happened anyway.” The story also articulates why the study design couldn’t determine if the intervention caused the benefits, and explains what the study was designed to do. Well done.

Does the story commit disease-mongering?

Satisfactory

No disease mongering here. Heart failure is a widespread problem.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

The story uses an independent source to good effect, which we are always glad to see. However, the story misses a key point in terms of conflicts of interest. While this specific study was funded by Japanese government agencies, the journal article notes that the research team also receives funding from TERUMO Company. TERUMO Company makes a product called HeartSheet, which Nature described in 2015 as being “made of skeletal-muscle stem cells that are taken from a patient’s thigh and grown in the lab. The sheet…is then applied to the hearts of people who have severe cardiac failure.”

In other words, the researchers receive funding from the company whose product they were testing — even though they don’t explicitly explain in the paper that what they are doing is virtually identical (if not identical) to TERUMO’s product.

Does the story compare the new approach with existing alternatives?

Satisfactory

This is a close one. The story doesn’t discuss alternative treatments, but it does make clear that the people who participated in the study “had debilitating symptoms despite standard heart failure therapies.” In other words, it makes clear that this was done after standard-of-care therapeutic options had been exhausted. That’s enough to merit a pass here.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

This is another strong point, with the story making it very clear that this is not a viable treatment option for the foreseeable future. “All stem-cell therapies remain experimental,” the story says at one point. Shortly thereafter, the story quotes a heart failure specialist as saying: “There’s no cell therapy we can offer patients right now.”

Does the story establish the true novelty of the approach?

Satisfactory

The story is very clear on this, explaining that previous heart failure treatments involving stem cells relied on injecting stem cells into the heart, whereas this study involved the creation of the stem cell patch and placing it on the heart.

Does the story appear to rely solely or largely on a news release?

Satisfactory

Goes well beyond a news release, and certainly far beyond what was provided in the news release from the American Heart Association.

Total Score: 6 of 10 Satisfactory

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