Intended for healthcare professionals

News

The Netherlands bans private stem cell therapy

BMJ 2007; 334 doi: https://doi.org/10.1136/bmj.39072.458449.DB (Published 04 January 2007) Cite this as: BMJ 2007;334:12
  1. Tony Sheldon
  1. 1Utrecht

    The Dutch government has banned the “clinical application” of controversial stem cell therapy being offered by private clinics in the Netherlands for conditions such as amyotrophic lateral sclerosis and multiple sclerosis.

    The ban has been imposed as part of a new regulation on the transplantation of stem cells governing the way in which they are used to regenerate different tissue and organs—for example, in the heart, liver, or kidneys.

    The ministry of health describes such therapy as “promising,” with “possible applications” in the future for Parkinson's disease, epilepsy, and amyotrophic lateral sclerosis. But it is concerned that “centres in the Netherlands are offering this form of treatment as if it is common practice” while in fact it is in the early stages of development.

    The ban, which came into force on 1 January, was imposed because of the therapy's associated health risks and the lack of proved effectiveness. It affects two private clinics in particular—the Preventive Medical Clinic in Rotterdam and Cells4health, registered near Zutphen.

    Many British patients have been treated at the Preventive Medical Clinic in the past two years. It was temporarily ordered to stop stem cell therapy in October by the Dutch Healthcare Inspectorate after a British patient became seriously ill after treatment (BMJ 2006;333:770).

    The Dutch health minister, Hans Hoogervorst, wrote to MPs, saying that present commercial stem cell therapy can endanger patients' health and that he shares the opinion of senior clinicians that it amounts to “dangerous quackery.”

    The new regulation cites a report published in May by Rotterdam University's Erasmus Medical Centre and the Institute for Medical Technology Assessment, which concluded that most stem cell therapy research was still in a preclinical stage. An appendix to the regulation emphasises that the differentiation of stem cells demands special expertise to prevent spontaneous growth or unstable or incorrect differentiation.

    In future, therefore, a licence will be required for stem cell transplantation. This would only be available to university hospitals and the Dutch Cancer Institute in the context of a stem cell therapy experiment covered by strict laws on medical scientific research.

    The head of the multiple sclerosis centre at the Erasmus Medical Centre, Rogier Hintzen, who earlier called for stricter regulation, said, “This was exactly what was needed to protect people against lax laws and false hope.” He said future useful developments would suffer if stem cell therapy today was done in a non-academic money-making setting, using less well defined science.

    Cees Kleinbloesem, the chief executive of Cells4health, said the regulation was regrettable and that the future for stem cell therapy was not in the Netherlands.