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Medical treatments that use stem cells have the potential to benefit patients facing serious diseases and injuries, but patients are not always aware that most treatments they are offered are experimental and can carry high risks, according to a report from Rice University’s Baker Institute for Public Policy.
The report, “Making Stem Cell Interventions and Advertisements Safer and More Effective in Texas,” by Kirstin Matthews and Akshaya Venkatesh examines the marketing of stem cell interventions (SCIs) in Texas and provides recommendations for addressing misinformation.
Stem cells can grow indefinitely and can differentiate into a wide variety of cell types, making them ideal as part of regenerative medicine treatments for blood, bones, lungs, skin and the brain. SCIs have been used in clinics around the world for the past 20 years, and there are currently more than 2,700 clinics in the United States—with a large share in Texas. But most SCIs lack evidence of safety or effectiveness, according to the report.
In 2017, Texas lawmakers enacted House Bill 810 to make experimental SCIs more accessible to patients with chronic or terminal illnesses. Yet patients are not always informed that these SCIs are experimental and carry risk, the authors wrote, with potentially severe side effects including infections, blindness, tumors and even death. While a few SCIs have been approved by the Food and Drug Administration (FDA) for blood-related diseases and cancers, most of them are still being studied and are in clinical trials.
“SCI advertisements often provide the reader with misleading and at times false information related to the risks and benefits of the procedure, making it difficult for the public to discriminate between accepted medical practice and unproven interventions,” the authors wrote. “Efforts by consumers to find safe and effective treatments are further complicated by less scrupulous clinics that promote their SCIs by only referencing certain aspects of biomedical and clinical research, as well as clinical regulation.”
One way some clinics try to legitimize their experimental SCIs is by registering their pay-to-participate trials on the website clinicaltrials.gov, which is not moderated by the FDA.
“The practice of registering trials without professional oversight hinders the ability of patients to separate legitimate trials from those without FDA approval and falsely suggests to patients that an experimental SCI is government-approved,” the authors wrote. “Other misleading tactics include patient videos emphasizing a positive outcome following an SCI and omitting any reference to severe or prevalent negative results.”
The authors propose three recommendations for improving patient safety and awareness in Texas: requiring clinics to display disclaimers about the experimental nature of SCIs, requiring advertisements declare the SCIs are experimental and creating a state medical board registry to report adverse SCI events. All three recommendations have the same goal: empowering patients to make informed decisions.
Avery Ruxer Franklin, Rice University