A clinician prepares a syringe containing stem cells used for therapy.Credit: Patrick T. Fallon/Getty

Many companies offering unproven stem-cell therapies in the United States do not employ clinicians with relevant medical training, an analysis has found.

Fewer than half of the 166 businesses analysed in the study employed physicians whose formal medical training covered the conditions the company claimed to treat, according to the paper, which was published on 25 June in JAMA1.

“This study highlights that patients need to be aware that many physicians who advertise stem-cell treatments are not only operating outside the bounds of scientific evidence, but outside their own professional qualifications,” says Douglas Sipp, a researcher at the RIKEN Center for Biosystems Dynamics Research in Kobe, Japan.

The only stem-cell-based products that are approved by the US Food and Drug Administration (FDA) as medical treatments are blood-forming cells used to treat certain blood and immune-system disorders. Stem cells taken from healthy bone marrow are also used in transplants to treat some cancers. Yet in the past decade or so, hundreds of clinics have sprung up in the country offering stem-cell treatments for a wide range of other conditions, including muscular dystrophy, Alzheimer’s disease and vision loss.

In the United States, stem cells can be extracted and reinjected into people without FDA approval as long as the cells have been only “minimally manipulated”. Companies have argued that their procedures therefore do not need approval — but many bioethicists disagree, claiming that many of the procedures they offer should be classified as drugs, biologics or medical devices, which the FDA must approve for use.

Background checks

The analysis looked at the websites of 166 companies that were advertising their services in January 2018 and that listed their clinical staff online.

Nine companies did not list any physicians. Five of these were staffed entirely by podiatrists; two by naturopaths, who use interventions such as homeopathy and acupuncture; and one by dentists.

Of the companies that employed doctors, just 81 listed physicians who had medical training that the researchers deemed was necessary to cover all of the conditions the firms’ clinics offered to treat (see ‘Stem-cell doctors’).

Source: Ref. 1

Businesses offering unproven stem-cell treatments for orthopaedic conditions — among the most common conditions for which such therapies are offered — were more likely to employ trained doctors: 77% listed one or more physicians with formal training in orthopaedics. But only 19% of practices offering to treat non-orthopaedic conditions employed physicians with relevant specialist training.

“Patients need to ensure they look at trusted sources of information and consider the backgrounds of physicians when considering medical care, including regenerative care,” says Zubin Master, a bioethicist at the Mayo Clinic in Rochester, Minnesota, who led the study. Master acknowledges that some of the physicians employed by the companies might have gained relevant further qualifications beyond their formal medical training.