According to Turner, these include stem-cell transplants for blood-related cancers and sickle cell maladies. When it comes to evidence-based, FDA-approved stem-cell therapies, the list of indications is short. In a statement published this year in JAMA, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, warned physicians of this new development, and asked for their help in cracking down on these clinics. “It deserves to have a light shown on it.”īut now, many of the same regenerative medicine companies offering unproven treatments are adding a new promise to their advertising copy: the prevention and/or treatment of COVID-19. “Many businesses appear to be violating federal law - and generating a lot of money by doing it - but are not really drawing the attention of investigators, regulators or journalists, and remain such a fundamental part of the marketplace,” Turner said. Globally, the regenerative medicine market, including direct-to-consumer stem cell therapy, is expected to reach $5.6 billion by 2025, according to a 2019 report from the market research firm ReportLink. In 2015, platelet injections for arthritis alone generated more than $93 million in revenue in the United States, according to a 2018 article in The Journal of Knee Surgery. When you think about regulatory activity with the FDA and the Federal Trade Commission, much of it has not been in the orthopedic or pain management space the focus instead has been on the companies making the especially egregious claims.” “It’s almost so widespread that their existence has kind of been normalized and routinized. “These are widespread advertising claims,” Turner said. It is to this population that regenerative medicine companies, through hundreds of sports medicine and pain management clinics across the country, direct their most enticing promises - that all patients have to do is take cells from bone marrow or blood, process it, and inject them back into the body, and it will have a variety of anti-inflammatory therapeutic effects. In the United States, more than 27 million people are affected by OA, with an estimated 9.9 million adults exhibiting OA of the knee. “While that is important and the misrepresentations are extreme, individuals with arthritis and similar conditions are really the bread and butter of this marketplace. “A lot of the times when people talk about this market, they are interested in the really far out claims, such as that they treat ALS or spinal cord injuries or Alzheimer’s Disease,” Leigh Turner, PhD, of the University of Minnesota Center for Bioethics and School of Public Health, told Healio Rheumatology. Source: Adobe StockĪlthough much of the attention surrounding unproven regenerative medicine has focused on the significantly flashier claims, it is the relatively lowkey promises related to arthritis and other orthopedic conditions that remain the industry’s main source of revenue. Many regenerative medicine companies offering unproven treatments are adding a new promise to their advertising copy - the prevention and/or treatment of COVID-19. It is a gray area of regenerative medicine that rheumatologists and orthopedic providers are typically familiar with, as the promise of stem cell injections to relieve joint pain or bypass invasive surgeries often resonates among patients with osteoarthritis. businesses aggressively pitch unproven stem cell products to treat a variety of conditions, ranging from autism to Parkinson’s disease to macular degeneration. Nature abhors a vacuum, and in the absence of evidence-based therapies to treat or prevent COVID-19, stem cell clinics with a menu of unsubstantiated direct-to-consumer therapies are more than willing to fill the gap.Īmbitious claims are not out of place in the realm of stem cell marketing, in which hundreds of U.S. If you continue to have this issue please contact to Healio
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