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Germany tightens law on stem cell treatments

BMJ 2009; 339 doi: http://dx.doi.org/10.1136/bmj.b2967 (Published 28 July 2009) Cite this as: BMJ 2009;339:b2967
  1. Ned Stafford
  1. 1Hamburg

    Treatments in Germany involving adult stem cells will be more closely regulated after revision of Germany’s medical products law received final approval by the Bundesrat, the upper house of parliament.

    The Bundesrat approved the revisions on 10 July, just over two weeks after the German Society for Neurology and the German Parkinson Society issued a joint statement warning that patients with Parkinson’s disease should not undergo treatments involving bone marrow stem cells. Such treatments are being offered around the world, including at the XCell-Center in Cologne, the societies said in the statement on 23 June.

    The XCell-Center began operating in Cologne in January 2007, since when “more than 1600 patients have safely undergone our various stem cell treatments,” the centre’s website states.

    The website (www.xcell-center.com), available in 10 languages, gives a detailed overview of treatments, describing bone marrow extraction; isolation, analysis, and concentration of the stem cells in the laboratory; stem cell implantation; and postoperative care. The website also explains the “limits of therapy.”

    Johannes Schwarz, a University of Leipzig neurologist acting as a spokesman on the issue for the Society for Neurology, told the BMJ that the societies had issued the statement because they believe that such treatments are not currently supported by scientific studies.

    Dr Schwarz and Alexander Storch, of the Department of Neurology at the Dresden Technical University, issued a letter in English for non-German speaking patients considering such treatments, stating, “In respect to bone marrow stem cell therapy of Parkinson’s disease, there are neither preclinical (animal experiments) nor clinical data that suggest efficacy.”

    The BMJ made several attempts to contact XCell-Center for a comment on the change in the law and whether it would be able to continue to operate but received no reply.

    Stephan Gierthmühlen, an attorney advising the Society for Neurology and the Parkinson Society on adult stem cell treatments, said that although the new law will allow closer regulation of adult stem cell treatment, it does not completely close the door to such treatments.

    He said that current law could be construed to mean that cells taken from a person’s body can be reinserted without clinical trial data or regulatory approval. The new law has added the word “unchanged” before cells, Mr Gierthmühlen said. This means that if extracted cells are refined or changed, then a stem cell treatment centre would have to gain regulatory approval before being able to reinsert the cells in the patient’s body.

    This leaves a grey area in the definition of “unchanged” cells that will be open to interpretation by German regulators of medical treatment, Mr Gierthmühlen said. Some treatment centres wash or clean adult stem cells before reinserting them in the body, and Mr Gierthmühlen said that he believes this would constitute a change in the stem cells.

    Another potential loophole for adult stem cell treatments in Germany is a new section, 4b, added to the law. Under section 4b new treatments can be approved without clinical trials if they are developed for a single patient, developed according to specific quality regulations, and administered in a clinical setting under the supervision of a medical doctor, said Mr Gierthmühlen.

    A spokesman for the German health ministry said that the revisions in the medical products law would take effect after the final text is officially published, probably in mid-August.

    The law will have an effect on XCell-Center, which is mentioned in the joint press release issued by the two societies.

    Klaus Cichutek, vice president of the Paul Ehrlich Institute, which is responsible for approving clinical trials and medicinal products in Germany, said, “For continued use of the respective medicinal products, XCell would need a clinical trial authorisation by the Paul Ehrlich Institute, followed by application to the EMEA [European Medicines Agency] for marketing authorisation of their medicinal product.”

    He added: “Under certain circumstances, which may not apply in the XCell case, the Paul Ehrlich Institute could provide a section 4b authorisation in the absence of clinical trial data.”

    Notes

    Cite this as: BMJ 2009;339:b2967