Published online 3 December 2008 | Nature | doi:10.1038/news.2008.1276

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Stem cell society urges action on bogus clinics

Regulators should protect patients by closing centres offering dubious therapies.

Stem cellsClinics that offer fraudulent therapies should be closed, the ISSCR says.Alamy

The International Society for Stem Cell Research (ISSCR) has warned against "fraudulent clinics" offering risky stem-cell treatments and has called for government authorities to shut them down in new guidelines.

In addition, the ISSCR patient handbook published alongside the guidelines provides a list of questions patients should ask future practitioners, such as whether a treatment is considered routine and what evidence has been collected to support it. It also warns against clinics that offer only testimonials as evidence and those that treat many unrelated diseases, particularly if they do so with the same cells. The society condemned 'stem-cell tourism' earlier this year (see 'Stem cell society condemns unproven treatments'), when it began soliciting public comments for the guidelines.

In an article1 accompanying a summary of the guidelines2 in Cell Stem Cell, Timothy Caulfield of the University of Alberta in Canada and his colleagues examined websites of clinics that advertise their services directly to consumers. Offerings included stem-cell treatments for autism, Parkinson's disease and spinal-cord injury, and of those that listed prices, the average cost was $21,500. Caulfield and his co-authors, who were not involved in drafting the ISSCR guidelines, describe the clinics' claims as "optimistic" and "unsubstantiated by peer-reviewed literature".

"The guidelines may not have the teeth of enforcement, but it does send a strong signal regarding what is acceptable and what is not," Caulfield says.

Many clinics in China, Thailand, India, Russia, the Caribbean and Latin America operate under a lax regulatory environment and researchers complain that few of these clinics provide details of their procedures. The society's new guidelines say that regulators in countries where illegitimate therapies are offered should "prevent exploitation of patients" and, if necessary, "close fraudulent clinics" and "take disciplinary action against the clinicians involved".

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."

Setting standards

At the moment, many clinics won't even tell scientists what types of cell they are using, says Insoo Hyun, a bioethicist at Case Western Reserve University in Cleveland, Ohio, and the other ISSCR taskforce co-chair. "We now have something we can point to [in order] to say that the clinics fall short," Hyun adds.

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The ISSCR guidelines say that for a small number of patients that are seriously ill, "clinicians may be justified in attempting medically innovative stem-cell based interventions" outside the setting of a proper clinical trial.

The society also details that informed consent should be obtained from patients and tissue donors, describes the kinds of animal study that could provide evidence that a clinical trial should go forward, and notes that patients should be monitored during and after a trial.

The members of the task force that drafted the guidelines represent 13 countries. Hyun says that the 30 members of the task force sought feedback from other groups working to move stem cells into the clinic: "[The guidelines have] been examined by key stakeholders internationally." 

  • References

    1. Lau, D. et al. Cell Stem Cell 3, 591–594 (2008).
    2. Hyun, I. et al. Cell Stem Cell 3, 607–609 (2008).
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