A controversial stem cell therapy center operating out of Düsseldorf and Cologne, Germany, has closed. The news follows an undercover investigation by the Sunday Telegraph which claimed that the clinic offered unproven and dangerous stem cell therapies to patients suffering from multiple sclerosis, spinal cord injuries, and strokes, including people from the UK.
In August last year, an 18-month-old Romanian baby died from internal bleeding after being injected in the brain with stem cells. In a separate incident three months before, a boy from Azerbaijan almost died after undergoing the same procedure, reported the newspaper.
The XCell-Center, which has not commented on its closure, opened in 2007 and charged patients up to £20,000 for procedures involving injecting stem cells into the brain, spine and other areas of the body. It continued to charge patients under a 'loophole' in the law, said the Sunday Telegraph, despite concerns about the safety and efficacy of the procedures offered.
In 2009 Germany implemented EU regulations to control the marketing of innovative biotechnological techniques, including stem cell therapies, which allowed member states to introduce their own laws to regulate non-routinely manufactured products – known as the 'hospital exemption' - under which XCell's procedures are believed to have fallen.
The Paul Ehrlich Institute, responsible for regulating and licensing biomedicine in Germany, permitted an 18-month transition period but this ran out for XCell in January 2011. Nature News reports the institute, which issued an order on 21 April prohibiting all procedures involving the transfer of stem cells, noted XCell did not then apply for licences for the procedures offered on its website.
The clinic's website says: 'Due to a new development in German law, stem cell therapy is currently not possible to perform at the XCell-Center'. It has told its patients that all appointments are cancelled until further notice.
A spokesman for the Paul Ehrlich Institute said: 'The situation is very complicated but the law on stem cell treatments has not changed. However we welcome the news that the XCell-Center is not accepting any more cases'.
If XCell wishes to continue to operate, the center will need to submit licence applications for its procedures to the institute or apply to the European Medicines Agency in 2012.
Ira Hermann, coordinator of the North Rhine Westphalia stem cell network, welcomed the closure saying that XCell was offering 'unproven treatments' and 'taking a lot of money from very vulnerable people'.
Professor Chris Mason, chair of regenerative medicine at University College London, said: 'This is excellent news for the European cell therapy industry. XCell had failed to demonstrate its treatments were either safe and effective or had scientific rationale'.