This news release describes a study that used stem cells in an attempt to treat men with erectile dysfunction (ED). The study followed 20 patients, but that is the only bit of numerical information that readers are given. The news release did not provide any actual results from the study, despite heralding it as a success.
The release was short on other essential information as well: it did not provide the cost of the procedure, explain any harms, or detail how patients could get access to the treatment. Also worryingly, the news release was based on a study that it was calling a clinical trial, despite the fact that there was no regulation or FDA oversight. Although it may seem like welcome news to men suffering from ED, the news release did not provide any convincing evidence that the treatment actually works.
ED is a common problem in men. It is typically associated with aging, but can be aggravated by risk factors such as high blood pressure, diabetes and cigarette smoking. It is also a common side effect of treatments for prostate cancer. Oral medicines, called phosphodiesterase inhibitors, are most commonly used to treat ED. When these medicines are not helpful, a variety of other treatments including medicines injected into the base of the penis, vacuum devices and surgical implants are sometimes used. None of these alternative treatments are ideal and thus efforts to find new therapies are reasonable. The broad use of stem cell therapies for many, very different conditions and the lack of high quality evidence of benefit suggests that these treatments currently reflect a fad in medicine. At present, there is no evidence to suggest that stem cell treatment for ED is either safe or effective compared to other available treatments.
As we’ve written (and spoken about) before, many other stem cell treatments exist in the “Wild West” of scientific research, where treatments are unregulated and unproven yet sold to patients for thousands of dollars.
The news release does not mention anything about the cost of the CaverStem procedure. A look on the company’s website FAQ section shows only that it is not covered by insurance, but there is still no mention of actual cost. Given that the piece claims commercialization is imminent, information about the cost of a procedure that is unlikely to be covered by insurance is warranted.
The news release didn’t quantify benefits in any way. We’re told only that they looked at 20 patients, but none of the endpoints of the study were listed. On the procedure website, they list the primary endpoint as “Safety and tolerability based on number and severity of adverse events,” but the news release doesn’t say how many patients, if any, experienced adverse effects.
The prior study cited was an uncontrolled study involving a total of 18 patients. Though initial results showed improved symptoms, the abstract mentions that the benefit declined over time and that repeat stem cell treatments may be needed.
The news release did not mention any potential harms of the stem cell treatment. Although stem cell clinics often tout the safety of stem cells because they come from within the patient’s own body, that does not mean that there are no risks to stem cell procedures. Only one stem cell procedure (a blood-derived stem cell treatment used for treating cancer and blood-illnesses) is currently approved by the FDA. All other stem cell therapies in the U.S. are experimental and unregulated by the government, including this CaverStem procedure. On his blog, UC Davis stem cell scientist Paul Knoepfler reminds patients seeking stem cell therapy that every medical procedure has side effects. “Different kinds of stem cells have variable risk profiles,” writes Knoepfler, “but if someone tells you that the stem cell treatment they are selling has no risks then that is a big red flag and I would walk away.”
Given the small number of men tested and the limited duration of follow-up, it is difficult to deem that this is a safe treatment.
It is hard to assess the quality of the evidence given that the news release does not provide any quantifiable data, except that there were 20 patients in the study (a very small sample size). However, one of the biggest concerns about this news release is that it is based on a so-called “clinical trial” that is unregistered and has no data available to the public. While the release itself describes the study as a “safety data analysis,” the CaverStem website calls the analysis a clinical trial. This is a common and misleading tactic of stem cell clinics, which often use the term clinical trial to add more weight to their evidence. The International Society for Stem Cell Research notes this on their blog, where they advise patients, “Beware of stem cell treatments offered without regulatory approval or outside the confines of a legitimate and registered clinical trial.” And although they cite other clinical trials in their news release (most notably a 2017 study from France), that does not make up for the fact that their analysis was not a clinical trial.
In one study cited that reports actual data, the authors of that study caution, “Given the lack of control group, we cannot eliminate the hypothesis of a spontaneous recovery in our study.” This study involved men with erectile dysfunction after treatment for prostate cancer. The current study of 20 patients also presumably involves no comparison group. Thus, any purported benefits may reflect factors beyond any potential benefit of the treatment itself.
The news release mentioned that there are about 30 million men in the United States affected by ED, and backed it up with statistics from the National Institutes of Health. No disease mongering here.
The population for this potential treatment are those men with erectile dysfunction who do not have an adequate response to standard medicines. This is still a very large group and the one published study focused on men with erectile dysfunction after treatment for prostate cancer.
The news release says in the second sentence that the trial was sponsored by Creative Medical Technology Holdings, the same company that is marketing the product. It’s good that this conflict of interest was disclosed.
The news release said that 9 million men affected by ED don’t respond to standard pharmacological treatments such as Viagra, Levitra and Cialis. However, it didn’t make any mention of other types of treatments, such as lifestyle changes (quitting smoking and drinking), psychological counseling, vacuum erection devices or surgery. There are a number of other treatments available for ED that is unresponsive to standard medications. None of these other treatments including devices, injections or surgical implants are ideal, so the search for new treatment options is warranted. But the unstated implication that stem cell therapy should be the next choice after a medicine trial is problematic.
The release appears to be overly optimistic in stating when this therapy may be available to patients. Moreover, other than the study site that performed this small trial, there is no mention of where this procedure may be had.
The news release did say that they expect “that the procedure will be available to patients that meet the eligibility criteria within the next 60 days.” Yet this statement raises some red flags. First of all, it does not say what the eligibility criteria are, which may give ineligible patients false hope. Secondly, the 60-day time frame is incredibly quick. Even after promising safety studies, most medications and procedures undergo a third study that looks solely at efficacy (the primary outcome of this study was listed as safety and tolerability).
The news release itself does not claim that the CaverStem is a novel procedure but the release is obviously promoting the treatment as a new option for patients. The release does refer to a European study as proof of efficacy and appears to claim that the same researchers were involved in this work.
Despite the fact that the news release insinuated that a clinical trial had been completed and that a new treatment for ED will be out in 2 months, the language of the release itself was quite constrained. There were none of the common sensational phrases like “breakthrough” or “miracle” or “novel treatment.” In language choice, the news release was satisfactory. Though the release implies benefit of this treatment, nothing actually states this is the case.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
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