Nearly 20 companies across the globe are peddling dubious stem
cell therapies directly to consumers, according to a study published today in
the journal Cell Stem Cell.
These companies, offering treatments for disorders ranging from autism and
Parkinson’s disease to spinal cord injury and heart disease, provide little proof
that their therapies are truly stem cells, and little experimental
evidence exists in the scientific literature to back their claims. The
treatments are expensive–Timothy Caulfield of the University of Alberta in
Canada and his colleagues found that the average price was about $21,500 among the sites listing price.
This micrograph shows a colony of undifferentiated human embyonic stem cells. Credit: Argonne National Laboratory
In the same journal, the International Society for Stem Cell
Research issued a set of guidelines to ensure responsible research. According
to a statement from the society, “These guidelines define a roadmap for
medical researchers and doctors, outlining what needs to be accomplished to
move stem cells from promising research to proven treatments for patients.”
“Stem cell research is progressing so rapidly and has sparked a lot of
interest in translational research [including] among patients in hopes for
therapies,” said Insoo Hyun, lead author of the paper outlining the
guidelines and an associate professor of bioethics at Case Western Reserve
University School of Medicine in Cleveland.
“At the same time,” he said, “legitimate science is speeding
ahead and getting to the point where there needed to be more of a road map to
take the basic knowledge to clinical applications.”
…
Different clinics in China (Beike Biotech), the Ukraine (ACT) and elsewhere
claim to have treated thousands of patients for neurological disorders
including multiple sclerosis, Parkinson’s disease, spinal cord injury and
Alzheimer’s disease, congenital conditions such as autism and cerebral palsy,
as well as allergies, heart conditions and even cosmetic procedures. However,
the University of Alberta team was unable to find any studies that had even
investigated stem cell therapy for Parkinson’s disease or for Alzheimer’s, for
example.
Nowhere, apparently, was there any authentication of whether the stem cells
actually were stem cells, or where they had come from.
…
“Most of the time, stem cell products are presenting entirely novel
products that are unpredictable in humans,” Hyun said. “Unlike drugs,
you can’t just create a batch and put them on the shelf and expect they will be
the same. We need uniform quality control and manufacturing. And if they’re
embryonic or pluripotent stem cells, they could form unwanted tissues or
tumors. So, we have to be very careful about following up and monitoring
patients.”
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A 2005 feature in Technology Review, “The Problematical Dr.
Huang Hongyun”, examined the practices of a Chinese
physician offering cell therapy for spinal cord injury.
It’s not clear what kind of impact the guidelines, which are not binding,
will have on companies and clinics offering these dubious treatments.
Olle Lindvall, a professor of neurology at Lund University in Sweden and one
of the two co-chairs of the task force, doubts that the guidelines will cause
clinics operating outside the scientific mainstream to reform. “More of
the clinics are interested in making money than in helping patients,” he
says. But, he adds, “we hope that governments and regulatory bodies will
act so that these clinics will have to close.”
