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Read Original Release

Kerastem gives thin summary of phase 2 hair growth procedure results

Rating

2 Star

Kerastem Reports Successful US Phase II Hair Growth Clinical Trial Results

Our Review Summary

This release reports on a small phase 2 clinical trial that tested a new surgical approach to treating hair loss.  It involves liposuction to remove specific fat cells, treating them and then re-injecting them into the scalp to foster hair growth. The trial itself is early, and small, with each experimental arm using less than two dozen participants.  The information it offers for positive results is insufficient for readers to really assess the change the treatment provides.  It fails to mention anything about costs or discuss any risks of this treatment, nor does it mention anything other than one alternative, and it does that in passing. The release appears to focus more on laying the groundwork for marketing this new treatment than it does providing information helpful for human health. It also medicalizes a condition that might not be that serious to many who have it.

To our knowledge the study results have not been published. There is a summary of the trial on ClinicalTrials.gov.

 

Why This Matters

Hair loss is a common result that comes with aging for a certain part of the population, both men and women. It’s a psychological issue for some; it causes no known medical problems. The National Institutes of Health suggests that it “affects an estimated 50 million men and 30 million women in the United States,” which represents a huge market for clinics working to remedy that. In fact, the release itself mentions that the “global hair loss treatment market generates more than $7 Billion annually.” Readers deserve much more useful information.

Criteria

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

Not Satisfactory

The only mention of money in this news release is the reference to the “global hair loss treatment market” which it says amounts to about $7 billion annually. There is no information on what the proposed new treatment might cost, or even what current typical hair loss treatments might run, so readers are at a loss to be able to consider the real value of a proposed new approach. Also, it is unlikely health insurance will pay for this.

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

Not Satisfactory

This release does provide some numerical data but it’s not necessarily helpful for the reader. It states that the new approach “achieved a statistically significant increase in mean terminal hair count, when compared to control.” It adds, “An average increase of 29 terminal hairs per cm2 of scalp was observed, corresponding to a 17% increase (p < 0.05) from baseline.” Later it says, “the low dose treatment group had an average increase of 29 hairs per cm2 of scalp, which corresponds to an increase of 2,900 hairs per 100 cm2 of treated scalp. While the average hair transplant today is between 1,900 to 2,200 transplanted hairs, patients with early hair loss are very often not candidates for hair transplantation.”  While the numbers are there, readers can remain confused.  How many hairs typically are on the head on average?  Would the increase shown in this research return the patient to what he or she would consider a full head of hair?  Since hair restoration is considered to be a cosmetic, rather than essential, procedure, readers need more information on the degree of change that results from this new approach.

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

Not Satisfactory

The release says that “All treatment arms of STYLE (the clinical trial) were safe with no serious adverse events reported.”  But that doesn’t seem to be enough. The procedures involved liposuction, an invasive procedure with a history of potential serious risks, but no mention of that is made. It also involves the injection of tissue subcutaneously, which carries its own set of risks.  And again, treatment for hair loss is a voluntary decision, not one that is medically necessary, so the risks to any cosmetic procedure should be clearly spelled out.

The release could have stated more clearly than it did that if the “dose” of fat cells is too high it can speed up hair loss:

“We were very pleased to see the positive results from the low dose arm and were surprised that the high dose ADRC’s + Puregraft fat treatment group, along with the fat alone group, observed a reduction, or no change, respectively in terminal hair counts. Stated otherwise, dosing and tissue purity matter.”

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

Not Satisfactory

To its credit, the release explains that the research is a “phase II, US multi-center, randomized, single-blinded, and controlled clinical trial.” But it also mentions that only 70 participants were enrolled and it doesn’t explain the distribution of women and men. According to the explanation of the trial on ClinicalTrials.gov, those participants were divided into groups of 20 each for the three experimental arms of the trial and 10 participants acting as controls. Those are small numbers and the results are very early, which should be pointed out in the release.

In addition, the release mentions that too high a dose can lead to hair loss but doesn’t provide any data on the amount of hair lost or how many volunteers experienced loss.

Does the news release commit disease-mongering?

Not Satisfactory

Hair loss is a normal possibility for a large portion of the population as they age. It isn’t an illness in its own right and, as we have said, “treatment” for hair loss is considered a cosmetic procedure, not a medical necessity. But the release mentions a potential market for early hair loss “treatment” of 40 million people, as if all of those people were candidates for this approach. The truth its, many people with baldness would never consider changing this normal condition — nor should they. This is a classical example of medicalizing a condition that is for most people a natural occurrence that poses no health risks.

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

Satisfactory

While it never states it specifically, this release mentions the study sponsor, Kerastem, 12 times in a seven-paragraph news release, so readers can assume this company funded the study. The release quotes two officials from the company but none of the researchers. And there is no mention of conflicts of interest in the release although the sites where the research was conducted appear to be all private clinics, which would benefit from positive coverage of this research.

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

Not Satisfactory

Since the release states that “patients with early hair loss are very often not candidates for hair transplantation,’ its clear that transplantation is one alternative. But there is no mention of the various drugs which have shown some success it treating hair loss.

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

Not Satisfactory

There is no mention in the release as to when this new approach for treating hair loss might be available. The release states it is seeking “distribution relationships outside of the United States” but makes no mention whether it is planning to market the procedure in the US or seek US regulatory approval.

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

Satisfactory

We’ll give this category a Satisfactory rating since this is a novel approach that differs from current treatments for hair loss.

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

Satisfactory

The release does not appear to use unjustifiable language.

Total Score: 3 of 10 Satisfactory

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