Jessica Lo Surdo and Ross Marklein do stem sell research at a lab on the National Institutes of Health campus in Bethesda, Md. U.S. FOOD AND DRUG ADMINISTRATION
Austin is a “hotspot”for clinics marketing stem-cell treatments directly to consumers. In 2017, 100 of the 716 clinicsin the U.S. that promoted the regenerative properties of stem cells to treat everything from dental problems to neurological diseases were in Texas. But there is limited research to prove the safety and efficacy of some of those treatments, and new researchsuggests there are unqualified people administering them.
Put simply, stem cells are generic cells, a kind of blank slate. They can multiply and develop into specialized cells, like muscle cells or red blood cells. Stem-cell treatments try to take advantage of that regenerative property to help fix diseased or damaged tissues in the body.
Research published last month in the Journal of the American Medical Associationfound about half the clinics in Texas, California and Florida that advertised stem cell-based procedures didn’t seem to have a doctor with "formal training matching the conditions [they] claimed to treat."
Leigh Turner, an associate professor at the University of Minnesota Center for Bioethics and one of the study's authors, said, for example, a clinic without a doctor with expertise in neurology or neurosurgery advertised stem-cell treatments for neurological disorders like ALS, multiple sclerosis and Parkinson’s disease.
Turner said stem-cell treatment for blood-related cancers and some immunological conditions is backed by numerous studies and has become standardized care. However, his research found businesses that advertised claims ahead of the evidence for treating other conditions.
The U.S. Food and Drug Administration has been cracking down on companies making “unsubstantiated claims about the potential for stem cell products to prevent, treat or cure serious diseases.”
In a statement last month, the FDA said clinics across the country falsely claim their products don’t fall under the agency’s regulatory provisions for drugs and biological products.
“These actors are taking advantage of patients, many in vulnerable positions with chronic or terminal diseases, by leveraging the widespread belief in the eventual promise of these products, flouting the statutes and our regulations,” the FDA said. “This ultimately puts at risk the very patients that [these companies] claim to want to help, by either delaying treatment with legitimate and scientifically sound treatment or, worse, posing harm to patients, such as blindness, infection or possibly death.”
That FDA statement came on the heels of a Florida case where patients became blind after receiving stem-cell treatments. According to the Department of Justice, the defendants marketed their products as “stem-cell-based treatments for a host of serious conditions and diseases, including Parkinson’s disease, spinal cord injuries, stroke, and traumatic brain injury.”
But their claims lacked proof of safety and efficacy – and FDA approval. The federal court ordered the company to stop manufacturing or distributing certain stem-cell products.
Researchers say operating without FDA approval is one of the problems. There are different levels of FDA oversight required for human cells and tissues based on the perceived risk to the patient.
Turner said companies providing direct-to-consumer treatment interpret regulationsin a way that places their products on a less restrictive level so they won’t need approval.
Mihnea Dumitrescu, a doctor at Precision Regenerative and Functional Medicinein Austin, said he sometimes offers regenerative cell treatments as part of a holistic solution. He said he doesn’t think clinics in Austin are intentionally misinterpreting regulations to face less FDA scrutiny.
“I think the problem we have in Austin in general is that people who are probably not competent enough to practice regenerative medicine are all of a sudden stem cell experts because it sells," he said.
"If you're a chiropractor and you claim to treat ALS with intravenous stem cells - you don't have to have a medical degree to see there's something wrong with that."
Making people responsible for their health doesn’t pay or make you popular, he said, but “telling them you can do a stem cell injection in their knee and make them all better and they don’t have to do anything else – that’s what pays.”
He said hopefully clinics doing the wrong thing will get caught and be closed.
“If you’re a chiropractor and you claim to treat ALS with intravenous stem cells – you don’t have to have a medical degree to see that there’s something wrong with that," he said.
Regulations in Texas may be becoming more lenient in certain cases. In 2017, the Legislature passed HB 810, which allows investigational stem cell treatments that aren’t FDA approved to be administered to people who are terminally ill or have severe chronic diseases.
Review boards are supposed to provide oversight. Critics think this might be opening the door further for clinics to practice unproven treatments.
David Bales, founder and chairman of the nonprofit Texans for Cures, said he wants to see more funding for quality scientific research in stem cell treatments. He pushed for a state-wide registry for all doctors using stem cells to document their treatments and their outcomes.
“We just want transparent collaboration because we think that’ll help the patients the best,” he said.
In the last legislative session, lawmakers passed HB 3148, which would add just such a registry – in 2027.
https://www.kut.org/post/texas-ranks-third-number-stem-cell-clinics-may-not-be-good-thing
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