Alta Charo, Warren P. Knowles professor of law and bioethics at the University of Wisconsin-Madison, is pictured in July 2013.(Photo: Jeff Miller, University of Wisconsin-Madison)
Three women between the ages of 72 and 88 suffered severe loss of vision after receiving injections of stem cells derived from their own fatty tissue, according to a 2017 paper in The New England Journal of Medicine. All three had paid $5,000 to a stem cell clinic in Sunrise, Florida.
In 2009, a Los Angeles woman in her late 60s had to have small chunks of bone removed from the tissue around her eye, after undergoing a new face-lift procedure that included an injection of stem cells, Scientific American reported.
The cells, obtained from her own fat, included mesenchymal stem cells thathelp form skeletal tissue, including bone and cartilage.
A decade ago, U.S. scientists worried about Americans flying thousands of miles and spending thousands of dollars only to get fleeced by stem cell clinics in the regulatory Wild West of countries like China, India, Mexico and Thailand.
Now it happens here.
RELATED: 20 years after the growth of human embryonic stem cells at UW, science faces new frontiers
Leigh Turner, an associate professor for bioethics at the University of Minnesota, found 716 stem cell clinics in the U.S and published a paper on the phenomenon in the journal Perspectives in Biology and Medicine.
Turner found many of the clinics claimed to use stem cells taken from the patients own fat; others said they use blood-forming stem cells obtained from bone marrow. The latter have been used for years to treat some cancers, mostly leukemia and lymphoma.
Turner discovered, however, that stem cell clinics are promoting their cells as treatment for a wide variety of illnesses, including orthopedic conditions, pain relief, neurological disorders, immunological diseases, cardiovascular diseases, kidney diseases, respiratory diseases, Alzheimers, aging, dental problems, vision loss, hearing loss and even hair loss.
The long list of applications for one treatment, experts say, is a tip-off that the claims are dubious.
Its extraordinarily unlikely that a single product is going to have a positive effect on a whole series of diseases, saidAlta Charo, a University of Wisconsin-Madisonprofessor of law and bioethics.
In his paper, Turner said that the FDA, FBI, the Federal Trade Commission and state medical boards all have powers to regulate various aspects of the burgeoning stem cell business.
However the appearance of a well-regulated and strictly overseen marketplace for stem cell products is misleading, Turner wrote. Many U.S. businesses currently advertising stem cell treatments appear to operate in violation of federal regulations because they lack FDA approval for products that require premarket authorization.
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There have been some enforcement actions. In 2017, FDA announced a crackdown aimed at unscrupulous actors in the stem cell business. Earlier this year the agency filed complaints seeking permanent injunctions against two stem cell firms: U.S. Stem Cell Clinic LLCof Sunrise, Florida, and California Stem Cell Treatment CenterInc.of Rancho Mirage, California.
John Gurdon, the Nobel Prize-winning British scientist, said by email that clinics using unproven treatments coulddamage public confidence in stem cell research.
I believe all medical treatments should be conducted based on sufficient scientific evidence, said Gurdon, who shared the 2012 Nobel Prize in Physiology or Medicine with Japanese stem cell scientist Shinya Yamanaka. Unproven treatments can, not only impose huge physical and financial risks on patients, but also lose the credibility of stem cell research. Our first priority should be to ensure patients safety as much as we can.
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