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

July 1, 2016 3:30 pm

Hundreds of clinics across the
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
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 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.”

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