This micrograph shows a colony of undifferentiated human embyonic stem cells. Credit: Argonne National Laboratory
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.
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.”
According to an article from HealthDay:
“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.”
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.
According to an article on the Nature news site:
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.”