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Ohio State’s claim of a research ‘breakthrough’ buries key info: it’s not in people

Breakthrough device heals organs with a single touch

Our Review Summary

Researchers at The Ohio State University Wexner Medical Center and Ohio State’s College of Engineering have published a research letter in Nature Nanotechnology showing that a new technology, called Tissue Nanotransfection (TNT), is able to reprogram skin cells to become vascular cells in mice who had badly injured legs that lacked blood flow. While this highly experimental approach is exciting, there is far too much speculation, particularly in the headline, that the results of this research can be applied to humans.

 

Why This Matters

If a simple, safe, effective and non-invasive technology can reprogram cells so as to repair injured tissue or help a person recover from stroke, then it would be a major medical advance.  As an experiment, the study shows some promise in animals but with so many missing pieces and the needed caveats to give context to this “proof-of-concept,” it’s not clear that this is relevant to humans.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

There are no discussions of cost, but because this is a technology already being touted as a “breakthrough” with wide applications costs should have been broached as part of the description.

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

Not Satisfactory

We are told that “..it is achievable, successfully working about 98 percent of the time,” yet there’s no accompanying description of what ‘works’ really means, how the technology benefit is measured, or how it would compare to a similar technology.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

While we are told that the “procedure is non-invasive,” and that “the cargo is delivered by zapping the device with a small electrical charge that’s barely felt by the patient,” this implies a safety that may not exist. The release should have described how well the “patients” (in this case pigs and mice) tolerated the treatment and what types of problems they might have developed. More importantly, it should also have warned that this experiment in a small number of animals might not uncover problems that would occur when used in a large number of people.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

Appropriate caveats about the very preliminary, murine (rodent-related) nature of this evidence was missing. Curing crippled rodents? Curing mice from strokes? Those are interesting first steps but they are a long way from what any human patient would consider a breakthrough. We need some proof here.

Does the news release commit disease-mongering?

Satisfactory

There is no disease mongering here.

Does the news release identify funding sources & disclose conflicts of interest?

Satisfactory

The release names the funders. The published research letter states researchers have no financial conflicts of interest.

Does the news release compare the new approach with existing alternatives?

Not Applicable

The release doesn’t mention any alternatives or reference previous experimental attempts to use this technology. However, the release claims that multiple conditions could be treated with the technology, so it would be difficult to mention the array of alternatives that might be applicable. If this technology becomes a realistic alternative in people then alternatives would be important to describe.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

From the final sentence we get a hint that applicability in humans is a long way off: “Researchers plan to start clinical trials next year to test this technology in humans.”

It’s important to note that potential treatments in mice fail to materialize as a treatment in humans about 95 percent of the time. The release should have been a lot more cautious and pointed out that this concept will require many years of study.

Does the news release establish the true novelty of the approach?

Satisfactory

A study co-leader states in the release: “With this technology, we can convert skin cells into elements of any organ with just one touch.” We’ll grant that this claim is novel, though we thought it needed more explanation. More description of what exactly makes the nanochip novel — borrowed from the description in the study summary — would have helped readers understand what’s new about the technology.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Not Satisfactory

Use of the word “breakthrough” in the release is unjustifiable. The breakthrough status in treating humans hasn’t been established (or tested) and so the headline is misleading. The title of the letter from which the news release is drawn is more restrained but very technical: “Topical tissue nano-transfection mediates non-viral stroma reprogramming and rescue.” The release should have been headlined with something between the two extremes that also highlights that this was animal research.

Total Score: 4 of 9 Satisfactory

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