Our Review Summary
A man with ALS participates in a fundraiser for research in New York City.
This story describes a small Phase 2 safety-focused trial of stem cell injections to treat amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. The trial involving 15 patients tested whether the stem cell injections, previously performed in low doses at Emory University, would be safe in progressively larger doses administered at multiple medical centers. The study was published in the journal Neurology.
There isn’t much news here; the question remains open as to whether stem cells could be a safe and effective therapy for ALS. Nothing from these studies suggest that this treatment may slow or reverse progression of ALS. Given that, the story did a good job outlining the harms and risks from the procedure, and it included quotes from independent experts. But it is another example of how stem cell therapies get news coverage, even when the research is still preliminary.
Why This Matters
ALS is a rapidly progressive, fatal disease that attacks the nerve cells that control muscles. It’s relatively rare, with 3.9 cases in every 100,000 Americans, according to the National Institutes of Health. Most people with ALS die from respiratory failure, usually within 3 to 5 years from the onset of symptoms, according to the NIH, though about 10 percent of those with ALS survive for 10 or more years. There is no cure, though the drug riluzole can prolong survival.
Converting patients’ stem cells into healthy motor neurons is one ongoing research pathway for a possible treatment. The concept of replacing these dying spinal nerve cells with new ones seems intuitively appealing, but it is unknown whether this could slow the progression or ideally reverse it.
Criteria
Not Satisfactory
There’s no mention of how much this procedure costs. Though this is still in its earliest stages, one could simply mention this issue, as it’s likely to be very expensive.
Satisfactory
Since this was primarily a safety study, there are no measurable benefits to quantify, and the story lets us know with this statement: “Unfortunately, the procedure provided no benefit to patients.”
We’ll count this as sufficient for a Satisfactory rating.
However, we encourage journalists to think twice about giving air time to early-phase trials, especially for stem cells. In many cases, there isn’t a lot to report yet, since benefits haven’t been established in any meaningful way. Better to wait until bigger trials are conducted, which was even implied with this ending quote in the story:
“We are just now getting started with testing our hypotheses about using stem cells as therapeutics,” Glass said. “We do not know if these treatments will work, and it will take time to test these therapies in a systematic and safe way.”
Satisfactory
The story provided a lot of detail on the harms noted in the study, earning it a Satisfactory rating in this criterion, albeit with caveats.
Certainly, the bar for safety may be lower for ALS than for other diseases, but we think the story misleads by calling the treatment “generally safe.” As the story explains, two of the 15 patients developed “severe complications,” including partial paralysis and “incapacitating pain.” More detail is warranted here. In fact, the 15 patients in the study experienced a total of 81 adverse events that researchers said were probably or definitely related to the treatment, mainly surgery. While most of these were not serious, they may have reduced the quality of life at least temporarily for patients who probably have little time left to live. In addition, these patients spent several days in a hospital going through an uncomfortable procedure.
Satisfactory
The story doesn’t explain much about how the study was performed nor its specific findings. But there are other details that help readers assess the status of the evidence.
For example, the story says “no unusual acceleration of disease occurred” and “the study wasn’t designed to measure effectiveness of the treatment.” And it ends with this quote: “Importantly, people should understand that, at least for neurological diseases like ALS, we are just now getting started with testing our hypotheses about using stem cells as therapeutics,” Glass said. “We do not know if these treatments will work, and it will take time to test these therapies in a systematic and safe way.”
Satisfactory
The story does not engage in disease mongering. In fact, it explains that ALS is rare.
Not Satisfactory
The story includes quotes from two people who are not involved in the research. However, it does not mention that the study was partly funded by Neuralstem, a biopharmaceutical company focused on stem cell technology. In addition, study authors have numerous financial ties that weren’t disclosed.
Satisfactory
The story mentions that there are no effective treatments available.
Satisfactory
The story quotes a lead researcher saying, “we are just now getting started with testing our hypotheses about using stem cells as therapeutics. … We do not know if these treatments will work, and it will take time to test these therapies in a systematic and safe way.”
Satisfactory
The story sufficiently provides context on past studies in this area to help readers understand where this research fits into the big picture.
Satisfactory
The story does not appear to rely on a news release.
Total Score: 8 of 10 Satisfactory
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