There are well-established, significant ethical concerns regarding the safety and efficacy of treatments offered by stem cell clinics. Much less is known about those actually providing these unproven interventions. The authors of a recent study examined their background and training.1

“We were interested in the extent to which it matched, or did not match, the marketing claims being made by these businesses,” says Leigh Turner, PhD, one of the study’s authors and associate professor at University of Minnesota Center for Bioethics.

Turner and colleagues investigated the three states with the most stem cell clinics (California, Texas, and Florida), using the database from a 2016 paper.2 Of 183 identified companies in those states, 166 continued to advertise unproven stem cell procedures in 2018, with 608 identified clinicians. The authors scrutinized what claims those clinicians made about themselves and their training that was posted on company websites. They confirmed these qualifications using state medical board-licensing databases.

For example, many cosmetic surgery clinics have started marketing stem cell treatments for people with neurological or respiratory diseases or spinal cord injuries. “This raises questions about whether people are operating in their scope of practice or far outside that,” Turner says.

More than half the clinicians were physicians. The most common nonphysicians associated with the clinics were physician assistants, nurses, and alternative medicine practitioners. Five clinics were staffed only with podiatrists, two with naturopaths, one with dentists, and one with practitioners with unclear qualifications.

Turner and colleagues did not evaluate clinical practices. They only looked at the extent to which the clinicians’ training and background matched, or did not match, the marketing claims the clinics made. “If you have someone with no relevant background and training, it raises a whole different set of questions about safety,” Turner says. For instance, someone who lacks training in performing bone marrow aspiration still may be injecting this into people with neurological conditions.

Seventy-seven percent of orthopedic clinics offering stem cell treatments were, in fact, staffed by individuals with a background in orthopedics. “When that subset of the marketplace made claims about stem cell treatments, they usually restricted these claims to orthopedic injuries and diseases,” Turner reports.

Some clinics offered stem cell treatments for ligament tears. “At least they had relevant training for the injuries they were claiming to treat,” Turner notes. However, he emphasizes that does not mean there is good evidence supporting the treatment in the first place. “There are still serious questions about the efficacy of the product that is going into people,” Turner cautions.

In the rest of the marketplace, fewer than 20% of clinicians have received relevant training for the diseases and injuries that they claimed to treat. “That is pretty unnerving,” Turner offers. “And we had a pretty low bar.”

If the researchers could find just one person with relevant training in orthopedics, they classified that clinic as equipped with relevant training in orthopedics. “It’s still possible that other individuals were providing treatment who did not have relevant training,” Turner notes.

The findings make it clear that stem cell treatments are offered by people with no relevant expertise, who are self-representing as experts. One ethical concern is that patients seeking treatment are unlikely to be able to protect themselves from misleading advertising produced by businesses making persuasive-sounding claims. “They don’t have ‘scam’ written all over them. They are doing everything they can to seem credible and legitimate and trustworthy,” Turner explains.

Even if potential clients do want to find out more about the background of those providing the treatments, they might not know where to look. Turner and colleagues called for state medical boards to consider conducting more investigations in this area. “It’s pretty clear: The problem is not so much regulatory gray zones; it’s that businesses are not complying with the law,” Turner says.

Disciplinary consequences might include imposition of emergency restrictions or license revocations, depending on the gravity of the violation. “But there first needs to be an investigation. Oftentimes, that’s not happening,” says Turner, adding that that boards could do a better job of curtailing misleading advertising. Boards may not take action without a persistent citizen demanding an investigation of a particularly egregious case. “It raises the question: If we think of medicine as a self-regulating profession, how well is that being done?” Turner asks. “Does the bar need to be lower in terms of triggering enforcement activity?”

The sheer number of stem cell clinics proliferating in certain markets makes it harder to find resources to police them all. “You’re left with regulators picking off the extreme outliers, the most outrageous businesses that attract critical news media coverage,” Turner observes. “The rest go unnoticed.”

REFERENCES

  1. Fu W, Smith C, Turner L, et al. Characteristics and scope of training of clinicians participating in the US direct-to-consumer marketplace for unproven stem cell interventions. JAMA 2019;321:2463-2464.
  2. Turner L, Knoepfler P. Selling stem cells in the USA: Assessing the direct-to-consumer industry. Cell Stem Cell 2016;19:154-157.