Stem cell clinics continue to thrive in the US and worldwide, building their business on misleading advertising and offering unapproved and unproven stem-cell-based interventions (SCBI).

A research recently published in Stem Cell Reports by Emma Frow, David Brafman, and colleagues from Arizona State University, asked what kinds of claims and evidence these clinics use to market their unproven “treatments” to consumers.

There are few approved and scientifically proven stem cell-based treatments available today. Examples include blood stem cells for treating disorders of the blood system, and stem cells from the cornea, the covering of the eye, to restore the eye surface after injury. For those treatments, a particular type of stem cell or stem cell-derived product is closely matched to the organ system to be treated.

On the opposite side of this spectrum are clinics offering SCBI, whereby so-called “stem cells” are taken from one part of a patient’s body (e.g. fat or blood) to be re-injected somewhere else the body without matching the type of stem cell to the disease or part of the body to be treated, following a “one size fits all” practice, based on limited scientific evidence.

In the study, researchers analyzed the websites of 59 stem cell clinics in the Southwest US to catalog the different types of evidence they used to market their treatments, ranking these types of evidence from weaker/less scientifically credible to stronger/more scientifically credible. A majority of businesses relied on types of evidence in the middle of the credibility spectrum, for example offering technical, text-book style descriptions of stem cells and procedures, and listing the medical qualifications and board certifications of their practitioners.

A majority also posted patient testimonials in support of their treatments, a less scientifically robust type of evidence. Potentially stronger forms of evidence, such as registered clinical trials or scientific peer-reviewed articles, were only invoked by a minority of businesses. In the four cases where registered clinical trials were mentioned, clinics did not make results available, or were not actually taking part in the trial.

Further analysis of the scientific articles listed on clinic websites revealed that only 2% of the articles provided direct evidence for the clinical efficacy of the treatments offered by that clinic; the rest of the papers provided ambiguous evidence or were not at all related to the marketed treatments.

These results highlight the complicated challenge faced by prospective customers and patients in evaluating the evidence provided by stem cell clinics to market their treatments. While board certification and scientific papers are often held up as markers of expertise, this paper reveals how important it is to look below the surface and closely evaluate whether the details really match the type of clinical treatment being sought.

Guidance from patient or research organizations such as International Society for Stem Cell Research (ISSCR) will be essential in helping patients to navigate their way through the business sector of unproven SCBI.

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