Stem cell treatment in Germany is under scrutiny after child’s death

The controversy over the death of a child after stem cell therapy at a private hospital in Düsseldorf reached the German parliament last week. In question time the opposition Social Democrat Party asked the government why it had not reacted more quickly to the recent events.

After the death in August 2008 of an 18 month old child with cerebral palsy who had been given a stem cell injection into the brain, the doctor who administered the injection is under criminal investigation for the death.

Annette Widman-Mauz, parliamentary state secretary at the Federal Ministry of Health, pointed out that it was the responsibility of the state of North Rhine-Westphalia and the regional medical association to intervene and that the federal government could not interfere with an ongoing legal investigation.

According to its website, the XCell-Center, based in Cologne as well as Düsseldorf, has attracted more than 3500 patients with incurable illnesses from all over the world since it was set up in 2007 (www.xcell-center.com). It claims that its technique for stem cell transplantation has had positive effects in treating 17 different chronic degenerative diseases, including cerebral palsy, multiple sclerosis, autism, Parkinson’s disease, Alzheimer’s disease, heart disease, diabetes, and spinal cord injury.

The treatment involves taking bone marrow from patients, harvesting stem cells from the bone marrow, and then reinjecting the cells into other parts of the body, including the brain, the spine, and the neck. The stem cell treatments cost between £10 000 (€11 500; $16 000) and £20 000.

In contrast to most other European countries, such as the United Kingdom and the Netherlands, where stem cell injections are allowed only within the framework of a clinical trial, such injections are permissible in licensed clinics in Germany. The XCell-Center is licensed by the district government where it is based.

A European Union regulation from 2007 now defines stem cell transplantation as medical treatment, and companies using it will have to prove that their treatments are effective and safe. Companies, including the XCell-Center, have until 2012 to compile the relevant evidence and in the meantime are entitled to continue to provide stem cell therapies.

In January 2007 the founder of the XCell-Center in Germany, Kees Kleinbloesem, had to close down his treatment facility in the Netherlands after the Dutch government made it illegal for private institutions to provide stem cell therapy (BMJ 2007;334:12, doi:10.1136/bmj.39072.458449.DB).

A statement from the XCell-Center says that the child’s death was not caused by the stem cells but by the injection into the brain. The official statement says: “Unfortunately, one of our neurosurgeons has, in our opinion, failed to correctly assess the risk-benefit ratio in a few patients.

“Consequently, after the first complication, the surgeon was issued a warning. After the second complication, the employment contract of this particular neurosurgeon was terminated. These complications occurred due to the surgery itself. Consequently these events are unrelated to the stem cells. The events were reported to the health authorities by XCell-Center.”

Christoph Kumpa, the public prosecutor in the case, said that the inquiry is “directed towards this specific doctor and her actions and not the firm.” He said that the XCell-Center was cooperating with his office.

The Paul-Ehrlich Institute, which regulates cell treatments in Germany, has produced a report after the death but no public statement yet. Ms Widman-Mauz quoted the report in the parliamentary hearing as saying that XCell’s procedure for injecting stem cells into the brain had been conducted with “damaging consequences” and was “precarious.”