07 FEBRUARY 2009
 
 Risks of online stem cell clinics 
The science behind stem cell treatment is still in the early stages 
“Patients with debilitating diseases such as multiple sclerosis and 
Parkinson’s risk being exploited by websites offering expensive stem-cell 
treatments.” The Times reported. It said that a study had investigated the 
websites of 19 companies that offer such therapies. Researchers found that 
most make inflated or over-optimistic claims about the benefits, are not 
backed by evidence and make little or no mention of the risks involved.

This study highlights the extent of the problem of direct-to-consumer 
advertising of stem cell therapies.

There are risks in buying anything claiming to have a health benefit over the 
internet. Stem cell treatment offered by seemingly legitimate clinics is no 
different. Stem cells are an accepted treatment for blood cancers, but this 
science is still in its infancy in terms of neurological treatments. The MS 
Society warns there is no evidence yet that the treatment repairs multiple 
sclerosis damage.

Anyone considering this sort of treatment is strongly recommended to discuss 
it with their GP first. The Department of Health has recently released a 
warning on unproven stem cell treatment.

Where did the story come from?
 
Darren Lau and colleagues from the Department of Public Health Sciences and 
Faculty of Law at the University of Alberta in Edmonton, Canada carried out 
this research. The work was funded by a grant from the Stem Cell Network. The 
study was published as correspondence in the peer-reviewed science journal, 
Cell Stem Cell.

What kind of scientific study was this?
 
The researchers say despite the fact that stem cell medicine is in an immature 
state, there is still an ‘early market’ for the supposed stem cell 
therapies, and people are beginning to buy the therapies directly. They 
believe that direct-to-consumer advertising through the internet is likely to 
play an important role in how this market develops. This cross-sectional 
descriptive analysis was aimed at answering three specific questions:

What sorts of therapies are being offered? 
How are they portrayed? 
Is there clinical evidence to support the use of these therapies? 
To investigate this, the researchers took a ‘snapshot’ of online stem cell 
clinics in August 2007, by carrying out a Google search using the terms 
‘stem cell therapy’ or ‘treatment’. This search returned 19 websites 
claiming to use stem cells to treat the disease. The researchers took the 
clinics’ uses of the ‘stem cell’ label at face value, meaning that they 
did not assess if the clinics were truly offering therapies with stem cells.

The researchers noted that the sites often offered other services including 
cosmetic treatments of otherwise healthy patients or health 
‘enhancements’. Importantly, these clinics also gave information on how 
the stem cells were given to patients.

They also say that it is usually difficult to sort the stem cells from other 
cells and that it is therefore likely that the ‘stem cell therapies’ 
referred to by the websites contain numerous other cells in addition to the 
stem cells.

What were the results of the study?
 
The researchers found that the most commonly provided stem cells were adult 
and taken from the patient’s own body (nine websites or 47%). These were 
followed by stem cells sourced from a foetus, cord blood or embryo. The stem 
cells were most often obtained from the patient’s bone marrow (seven sites 
or 37%) and/or blood (five sites or 26%). Some websites did describe getting 
the stem cells from patient fat, blood or marrow donors, aborted foetuses, 
patient’s skin, animal tissues and human placental tissue.

The websites claimed that treatments were most commonly administered by 
infusion into cerebrospinal fluid by lumbar puncture (six sites or 32%). 
Injection into a vein was equally common. Four websites described procedures 
for injecting the stem cells into deep body cavities, such as the space 
around the brain or by injection directly into the spinal cord.

The conditions treated were diverse, including neurological conditions or 
brain diseases such as multiple sclerosis, stroke, Parkinson’s disease, 
spinal cord injury and Alzheimer’s disease. The sites also claimed to treat 
allergies and congenital diseases, mainly cerebral palsy, autism and Duchenne 
muscular dystrophy.

Regarding the portrayal of risks and benefits, all 19 websites advertised 
improvement in the disease state as a benefit of therapy and most (14 or 74%) 
of the sites did not mention particular risks.

The last part of the study was to look for the evidence supporting stem cell 
treatments. For this, the researchers performed a database search (Pubmed) in 
July 2008. They looked for human studies that reported the clinical effects 
of stem cell therapies for any neurological or cardiovascular conditions 
mentioned 10 or more times by the websites. This search provided a range of 
trials (mostly randomised controlled trials) of low-level evidence (i.e. 
varying quality) for neurological conditions and four systematic reviews with 
meta-analyses for stem cell treatments after heart attack.

All of the systematic reviews reported a small but statistically significant 
advantage of about 2-3% in a measure of heart function, but the researchers 
say this was of uncertain clinical importance. For stem cell therapies for 
multiple sclerosis, Parkinson’s disease, stroke, Alzheimer’s disease, and 
spinal cord injury they found that the treatments offered on stem cell 
websites are generally unsupported by the clinical evidence.

What interpretations did the researchers draw from these results?
 
The researchers concluded that direct-to-consumer portrayal of stem cell 
medicine is optimistic and unsupported by published evidence. They also 
suggest that the results have other implications including:

Providers are making inaccurate claims in their direct-to-consumer 
advertising. 
Importantly, patients may not be receiving sufficient and appropriate 
information and may be being put at increased risk. 
Clinics may also be contributing to a public expectation that exceeds what 
this field of research can reasonably achieve.
What does the NHS Knowledge Service make of this study?
 
The researchers mention some limitations to the methods that they used to 
collect the data:

The information available from websites may not be the same as the information 
actually shared with patients in the clinic. 
The overall data was collected from a diverse range of clinics. The results 
cannot therefore be used to evaluate the claims of any particular clinic. 
The researchers did not directly assess the accuracy of the websites’ claims 
by analyzing the results of treatment they had carried out.
These are valid points. The researchers also say that even if improvements had 
occurred, it would be impossible to say with confidence that these were due 
to the treatment. If on the other hand the treatments did not work, then 
patients would have been subjected to inappropriate risk and the cost of the 
treatment. The average cost of a course of therapy among the four websites 
that mentioned costs was $21,500, excluding travel and accommodation for 
patients and caregivers.

There are well-publicised dangers in buying anything claimed to have a health 
benefit over the internet. Stem cell treatment offered by seemingly 
legitimate clinics is no different, especially considering the various 
sources of the stem cells, the deeply invasive methods in which they can be 
delivered and the fact that this science is still in its early stages.

New guidelines have just been released by the International Society for Stem 
Cell Research (ISSCR). 

A patient handbook is included that also lists some of the claims made by the 
websites, those that patients should interpret with caution.
Labels: Stem Cells

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