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Unproven and unregulated stem cell therapies for treatments for conditions ranging from Parkinson’s disease to multiple sclerosis to macular degeneration are putting patients at risk in a market that has grown rapidly in recent years.
In a paper published Aug.1 in the journal Stem Cell Reports, Arizona State University investigators offer a detailed characterization of nearly 170 direct-to-consumer stem cell businesses across six southwestern states. The study focused on Arizona, California, Colorado, Nevada, New Mexico and Utah, where the researchers estimate that about one-third of all stem cell clinics in the U.S. are located.
Currently, the only stem-cell based products that are FDA-approved are from cord blood or bone marrow and are approved only to treat cancers of blood and bone marrow. Yet many of the clinics included in the study are using fat-derived stem cells in treatments that have not undergone clinical trials for a wide range of diseases.
It turns out relatively little is known about the clinics that deliver stem cell treatments or how their procedures align with the expertise of the practitioners providing them.
“Previous studies have built up a broad picture of the direct-to-consumer stem cell industry,” said Emma Frow, an assistant professor with science policy expertise in the School for the Future of Innovation in Society and the School of Biological and Health Systems Engineering at Arizona State University who the is co-senior author of the paper with David Brafman, a stem cell bioengineer also with the School of Biological and Health Systems Engineering.
“Like others, I had significant concern about the impact these clinics could have on vulnerable patient population as well as the perception of the legitimacy of stem cell-related research as a whole,” Brafman said. “As a scientist, I was also fundamentally interested in these clinics in a more general sense. What type of treatments were they offering? What diseases were they claiming to treat? How were they supporting such claims?”
The researchers conducted extensive online searches for stem cell clinics in the six states.
“We took a deeper dive into a smaller number of clinics and found that there’s a lot of variation among the businesses offering these services,” Frow said. “About 25% focus exclusively on stem cells, but many others are facilities like orthopedic and sports medicine clinics that have added stem cells to their roster of services on offer. For these clinics, it’s very difficult to know how much of their business comes from stem cell treatments.
“There’s no exhaustive list of all the clinics that exist,” Frow said. “This is a lively marketplace, with businesses opening and closing and changing their names.”
For the 169 businesses identified, the researchers catalogued the treatments being offered, the medical conditions the clinics purported to treat and the types of cells they claimed to use.
For the clinics focused solely on stem cells, they also looked at the stated expertise of the care providers in relation to the medical conditions they offer to treat with stem cells.
“Just because someone is board certified doesn’t necessarily mean they are qualified to provide stem cell treatments," Frow said. “You really need to ask what they are board certified in and whether their medical expertise is well-matched to the condition you are seeking treatment for.”
The researchers found that orthopedic, inflammatory and pain conditions were the main types of medical conditions treated with stem cells at direct-to-consumer stem cell clinics in the Southwest.
Frow notes that these types of conditions “tend to be chronic problems that often are not curable. The market has really capitalized on targeting conditions that are hard to manage with existing therapies.”
Earlier studies have shown a lower percentage of clinics treating inflammatory conditions. “This could mean that the number of clinics treating inflammatory conditions is on the rise or that, in the Southwest, there is more focus on treating inflammatory conditions than in other parts of the U.S.,” Frow said.
The researchers also found differences in the degree to which the stated expertise of care providers matched the medical conditions they treat with stem cells.
For example, they identified that specialists in orthopedics and sports medicine were more likely to restrict stem cell treatments to conditions related to their medical specialties, while care providers listing specialties in cosmetic or alternative medicine were more likely to treat a much wider range of conditions with stem cells.
“We have been able to identify important trends that will have significant impacts on informing vulnerable patient populations, making recommendations for future regulatory enforcement and conveying urgency for policy changes," Brafman said.
Public discussions of direct-to-consumer stem cell treatments usually treat clinics as though their business models were all similar, but this study highlights key differences across these clinics.
“We think it makes a difference whether a business is focused solely on stem cells or offers it as one treatment among many,” Frow said. “And we think it’s important to pay attention to the medical qualifications and expertise of the care providers offering stem cell treatments. We want to bring more transparency to discussions of the direct-to-consumer stem cell marketplace and to empower consumers to figure out what kinds of questions to ask when they’re considering treatment.”
Top photo from Pixabay