German stem cell clinic closes after death of baby

From The Telegraph in the UK:

The closure of the XCell-Center in Dusseldorf follows an undercover investigation by The Sunday Telegraph into its controversial practices, which attracted hundreds of patients from the UK. The clinic charged patients up to £20,000 for stem cell injections into the back and brain despite a lack of scientific proof that the treatments actually worked.

Experts in stem cell research had accused the clinic of preying on vulnerable patients, desperately seeking a cure for such illnesses and diseases as cerebral palsy, multiple sclerosis, autism, Parkinson's, Alzheimer's, heart disease, diabetes and spinal cord injuries.

While most other European countries - as well as the US, Canada and Australia - have banned stem cell treatments unless shown to be safe and effective, XCell had exploited a loophole in German law allowing it to charge for the experimental procedures.

But last week, the clinic suddenly announced it had ceased carrying out operations due to what it described as legal changes in Germany. In a posting on its website, XCell said last week: "Due to a new development in German law, stem cell therapy is currently not possible to perform at the XCell-Center. Regretfully for this reason, we must cancel your appointment until further notice. We will notify you for further updates about the matter."

The clinic had come under increasing scrutiny following the death of an 18-month-old boy in August last year, in a case first revealed by The Sunday Telegraph. The child, who was from Romania, was injected in the brain with stem cells but suffered internal bleeding. Three months earlier, a boy aged 10 from Azerbaijan had almost died when the same procedure went wrong. The doctor who carried out the operation remains under criminal investigation.

The Sunday Telegraph now understands that following this newspaper's report in October, German authorities decided to re-examine the legality of the XCell operation. The centre had previously had permission to practice for a transitional period because it was already up and running when a law came into force in 2009 banning the commercial exploitation of unproven stem cell treatments.

It appears German authorities have now decided to close the loophole with immediate effect. They deny the law has changed and sources suggested they decided abruptly to re-interpret it instead.

A spokesman for the Paul-Ehrlich Institute, which regulates medicines in Germany, 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."

Ira Hermann, who runs the German stem cell network which funds scientific research projects, said: "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."

The clinic's sudden closure has taken would-be patients by surprise and left them confused. Some have been told the shut down is temporary and others that it is permanent. They had pinned their hopes on the promise of possible success for currently incurable illnesses.

On a Facebook page, one Australian patient posted: "Could you please tell me the approximate waiting list after sending the deposit. We sent the deposit more than two weeks ago and have not heard back even after emailing. We have also called the clinic and left messages for our contact to get back to us to no avail. We are getting a little worried."

Carol Walmsley, who lives in the Isle of Man, had hosted a charity night for her son Chris, quadriplegic after a car accident, only last Sunday. Raising the £15,000 needed for his treatment, she telephoned the XCell the following day only to be told the clinic was no longer accepting patients.

"It devastated me," said Mrs Walmsley, "They said they were cancelling all operations because they were unable to make any appointments. They said they were booking a meeting with the German government to sort this out. They told me they were fairly confident but there were no guarantees."

The XCell clinic treated about 25 patients a year from the UK in state of the art facilities in Dusseldorf, occupying two floors of a general hospital on the outskirts of the city overlooking the River Rhine. The clinic used modern equipment and claimed great success for its treatments although it was always careful not to offer guarantees of cures to patients. The treatment involved taking bone marrow from patients, harvesting stem cells from the bone marrow and then reinjecting those stem cells into other parts of the body.

The clinic did not appear to offer up its claims to independent scrutiny while experts suggested any improvement in condition reported by patients after treatment could be caused by the placebo effect.

A doctor at the clinic told a Sunday Telegraph undercover reporter, who suffers from multiple sclerosis and is confined to a wheelchair, that he might walk again should he agree to the stem cell treatments.

The XCell-Center did not respond to inquiries from The Sunday Telegraph.