The elaborate webpage of one of the world’s most notorious stem cell-therapy clinics – where an 18-month old boy died, and a ten-year old boy nearly died, under treatment last year – shrunk dramatically last week. Now there is just a single, short – and somewhat disingenuous – page. ‘Due to a new development in German law, stem cell therapy is currently not possible to perform at the XCell-Center’, the page says. ’Regretfully for this reason, we must cancel your appointment until further notice.’
The centre, which has units in Düsseldorf and Cologne, opened in 2007. It offered treatments involving manipulating stem cells derived from bone marrow and injecting them into the brain, spinal cord or other body parts of patients. German stem cell scientists were quick to criticise its brazen claims that the transplanted stem cells could even help heal devastating neurological diseases such as multiple sclerosis or the consequence of stroke.
Despite their expressions of concernand numerous exposés in the media describing some of the therapies to be at best useless and at worst dangerous, the centre continued to operate, attracting thousands of patients each year. Treatments cost up to €26,000.
The problem became apparent when the European Union attempted to control innovative new therapies based on biotechnological or tissue engineering – including cell-based therapies – in a 2007 regulation which introduces an EU-wide licence recommended by the European Medicines Agency. In Germany, hospital doctors had been allowed to use such therapies without a specific license on an experimental basis on individual patients.
The regulation was implemented into German law in July 2009. It included a so-called ‘hospital exemption’ allowing EU member states to regulate non-routinely manufactured products according to their own national laws. The Paul Ehrlich Institute, the federal biomedicines authority, was put in charge of authorising hospital exemptions in Germany. But an 18-month transition period was allowed for tissue-engineered already being manufactured non-routinely, like the XCell stem cell therapies.
This is why XCell had been able to continue operations. But when the transition period ran out in January this year, the Paul Ehrlich Institute noted that the company had not applied for licenses covering all of the medical therapies they offered on their website. It issued an order to cease operations involving transfer of stem cells on 21 April. That order was executed by the regional health authorities within a few days.
In fact, the Paul Ehrlich Institute had already issued a report to the regional health authorities last year, after the death of the 18-month old, declaring that XCell’s products and procedures for injection of stem cells under the arachnoid membrane of the brain and spinal cord were unsafe and should therefore not be used.
The company is not speaking to the press.
If XCell wishes to apply for licenses to continue some of its activities this year, it will have to submit a formal application to the Paul Ehrlich Institute supported by data on proof-of-concept studies, says the institute’s president Klaus Cichutek. Otherwise it will have to apply to the European Medicines Agency in 2012, providing also supporting clinical trial data. “We will support any company’s efforts to develop advanced therapies in authorised controlled clinical trials, if the benefit-risk ratio is acceptable,” says Cichutek.
Local public prosecutors are considering charges of malpractice and mismanagement against an XCell doctor and the company’s management. Stem cell scientists in Germany and elsewhere are also concerned that the XCell affair could taint prospects for future stem-cell based therapies.