Hundreds of clinics across the United States sell unapproved stem cell treatments

Hundreds of clinics across the United States are marketing unapproved stem cell treatments for conditions ranging from aging skin to spinal cord injuries, a new study finds.

More than 500 clinics across the United States are marketing unapproved stem cell treatments for conditions ranging from Alzheimer's to cosmetic enhancements, a new study finds.
In an online survey, researchers found at least 570 clinics offering unapproved stem cell "therapies" in states across the country.
Most often, the clinics market stem cell procedures for orthopedic conditions, such as arthritis and injured ligaments and tendons. This does have science behind it, but is still experimental, medical experts said.
"In almost every state now, people can go locally to get stem-cell 'treatments," said Paul Knoepfler, a stem-cell scientist at the University of California at Davis School of Medicine and one of the authors of the study, published Thursday in the journal Cell Stem Cell.
"What worries us is the possibility of serious harm to patients," said co-author Leigh Turner, an associate professor at the Center for Bioethics at the University of Minnesota.
"I think there's a misperception that everything here [in the US] is regulated," Turner said. "But these clinics are operating here unregulated, and on a relatively large scale."
Stem cells are primitive cells with the potential to mature into various types of body tissue. Medical researchers have been studying the possibility of using stem cells to repair damaged tissue in a range of chronic ills -- with limited success so far.
Arthur Caplan, a bioethicist who was not involved in the study, said it’s known that some patients have been seriously harmed during the stem cell treatments.
"Many of these claims are outrageous," Caplan said. "These clinics are preying on vulnerable people."
The US Food and Drug Administration (FDA) has approved only a few stem-cell treatments and says treatment for most conditions are still largely unproven.
The FDA is now taking steps against specific clinics. Last year, it sent a warning letter to a network of companies that operate in California, New York and Florida.
"In theory, stem cells may advance the treatment of many other diseases or conditions; however, at this time, the value of stem cells as a treatment for most conditions is largely unproven and more information is needed about their potential benefits," the FDA said in a statement.

US scientists are alarmed at unapproved stem-cell clinics marketing treatments for a range of medical conditions, as well as for cosmetic enhancements. Photo / iStock

For years, American "stem-cell tourists" have flocked to unregulated clinics in Mexico, the Caribbean and China in search of everything from heart treatments to facelifts. But now, these kinds of clinics are popping up across the United States.
According to a new study, at least 351 companies with 570 clinics are marketing unapproved treatments for conditions such as osteoarthritis, Alzheimer's, autism and injured spinal cords, as well as for cosmetic enhancements.
"In almost every state now, people can go locally to get stem-cell 'treatments,'" said Paul Knoepfler, a stem-cell scientist at the University of California at Davis School of Medicine and one of the authors of the study, published today in the journal Cell Stem Cell. "That's different from what we typically think about when we think of stem-cell tourism."

The clinics were found all across the US. Source: "Selling Stem Cells in the USA: Accessing the Direct-to-Consumer Industry," by Leigh Turner and Paul Knoepfler, Cell Stem Cell, Vol 19; August 4, 2016

Knoepfler and his co-author, Leigh Turner, associate professor Center for Bioethics at the University of Minnesota, didn't accuse the clinics of operating illegally, but called on US federal officials to step up their oversight. "What worries us is the possibility of serious harm to patients," said Turner.
Stem cells are a source of keen interest because they can be coaxed into becoming almost any type of cell, and thus might offer remedies for many medical problems. But they also carry risk; they can form tumours and migrate to parts of the body where they don't belong.
For the study, the researchers scoured the Internet for businesses engaged in direct-to-consumer marketing of stem-cell procedures. Many of the clinics were in California (113), Florida (104) and Texas (71). Certain cities, including Beverly Hills, New York and San Antonio, were "hotspots." Almost two-thirds of the businesses offered procedures involving stem cells derived from a patient's own fat; almost half performed treatments using bone marrow.
The Food and Drug Administration has approved only a very few stem-cell treatments. In the vast majority of cases, the procedures being conducted in the clinics are not approved, are outside clinical trials and can cost patients thousands of dollars.
The new analysis comes as the debate over regulating stem-cell clinics is intensifying. While some critics say the FDA should crack down on the industry, others say they shouldn't face new restrictions because what they are doing is part of the "practice of medicine".
Michael Werner, executive director of the Alliance for Regenerative Medicine, which represents companies, patient advocates and researchers, said group thinks FDA oversight is critical. He said "the proliferation of the so-called stem cell clinics is potentially harmful because the treatments may not undergo, or have not undergone, the appropriate scientific rigour that takes place in evaluating new technologies and new medical treatments."
But Marc Scheineson, a former top FDA official who advises the Bipartisan Policy Center on medical innovation, said the current FDA regulatory regime is "archaic" and is stifling medical innovation.
As the issue heats up, the FDA has scheduled two public meetings in September to get public comment on draft guidance language on stem cells.
In a statement, the agency said, "In theory, stem cells may advance the treatment of many other diseases or conditions; however, at this time, the value of stem cells as a treatment for most conditions is largely unproven and more information is needed about their potential benefits."
The agency added that it is "concerned that the hope patients have for treatments not yet proven to be safe and effective may leave them vulnerable to unscrupulous providers of stem cell treatments that are illegal and potentially harmful."