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 Found in embryos, umbilical cord blood and adult bone marrow, stem
cells have the potential to develop into any type of specialized
cell in the body.
Stem cells can be used to help repair areas damaged by disease or
injury, according to the U.S. Department of Health and Human
Services.
In the U.S., stem cell therapies generally require Food and Drug
Administration approval before they can be marketed, and the FDA has
only approved one product so far, for blood disorders.
But many clinics in the U.S. now advertise a variety of stem cell
treatments that have not been approved, ranging from cosmetic
procedures like facelifts and breast enlargement, to therapies for
neurological diseases or sports injuries, according to the new
study.
“Many of these marketing claims raise significant ethical issues
given the lack of peer-reviewed evidence that advertised stem cell
interventions are safe and efficacious for the treatment of
particular diseases,” the researchers write in the journal Cell Stem
Cell.
Searching the internet, the researchers found 351 companies
marketing unapproved stem cell procedures at 570 clinics in the
U.S., most commonly in California, Florida, Texas, Colorado, Arizona
and New York.
These procedures are not heavily regulated because they use cells
from a patient’s own body. But earlier this year, the FDA issued
draft guidelines asserting that the stem cells used in most
procedures are drugs and should require a rigorous approval process
before they can be used. The draft guidelines will be discussed
further at a public hearing in mid-September (http://bit.ly/1RoFZe1).
Unapproved stem cell therapies have no conclusive evidence of safety
or effectiveness, Turner said.
“If you’re thinking about having an unapproved stem cell treatment,
there are things you can look for,” he said. “If a place offers one
treatment for 30 to 40 diseases, it’s extremely unlikely that it’s
going to be effective.”
It’s not surprising that people with terminal or degenerative
diseases would seek solutions on the internet, or that businesses
would be able to take advantage of these vulnerable individuals,
charging them $30,000 for a treatment that doesn’t improve their
health, he said.
“We’re all a lot more vulnerable to businesses making inaccurate
marketing claims than we might think,” Turner said.
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He said he doesn’t mean to suggest that all uses of stem cells are
dangerous or unethical, as approved stem cell treatments for
conditions like leukemia can be life-saving.
“It is the wild west, there are lots of clinics making all kinds of
promises they can’t necessarily deliver on,” said Mary Ann Chirba,
professor of legal reasoning, research and writing at Boston College
Law School, who was not part of the new study. “But that’s not to
say that all clinicians who are working in this area are
charlatans.”
There’s a “clumsy architecture” for regulating emerging therapies,
Chirba told Reuters Health by email.
“Any responsible person, myself included, wants regulation,” but the
rules currently in place are not effective, and the draft FDA
guidelines may actually be too restrictive, and make it too
difficult for patients to get access to these types of treatment at
all, she said.
In the meantime, the FDA cautions on its web site, “If you are
considering stem cell treatment in the U.S., ask your physician if
the necessary FDA approval has been obtained or if you will be part
of an FDA-regulated clinical study. This also applies if the stem
cells are your own. Even if the cells are yours, there are safety
risks, including risks introduced when the cells are manipulated
after removal.”
SOURCE: http://bit.ly/29qbjj3 Cell Stem Cell, online June 30, 2016.
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