'Stem cell ferry' gets round EU rules

Controversial stem cell therapy is to be provided in the UK on overnight ferries sailing in international water in order to bypass EU regulation. Advanced Cell Therapeutics (ACT), a Swiss company which offers treatment to sufferers of neurological disorders at twelve clinics around the world including some in Holland and Spain, was recently ordered to stop operating in Ireland by the Irish Medicines Board. Dr John Dunphy, who runs the Road Medical Centre in Carrigaline, Cork, where the therapy was being offered, is currently being investigated by the Irish Medical Council. Under new EU regulations, which came into force on 7 April, in order for the Cork clinic to operate using human cells or tissue for human application a licence must be obtained from the Irish Medicines Board.

ACT claims that the stem cells used in their therapies are derived exclusively from umbilical cord blood, donated using informed consent protocols, and that all cells are tested for infectious diseases. Last week, Dr Dunphy explained the process of administering the treatment to the Irish Medical Times - a local subcutaneous injection of 1.5 million stem cells is made, usually over the cervical or lumbar spine, when targeting neurological disorders. Four hundred UK patients were scheduled to undergo the treatment over the next four weeks; these patients have now been informed that their initial examination and preliminary consultation will take place in the Cork clinic with administration of the stem cells taking place in international waters aboard the Cork to Swansea ferry. The cost of the return ferry and one night's accommodation will be covered by ACT. ACT treatments are reported to cost up to £12,000.

Founders of the company which used to provide the stem cells to ACT for their treatments are currently facing a 51-count indictment from a federal grand jury in Atlanta, US, accused of distributing untested stem cell treatment drugs without any basis in science, and providing false and misleading information about the effectiveness of stem cell treatment. The company, Biomark International, which closed in 2003 after a Food and Drugs Agency investigation, also shared members of its advisory board and patient case histories with ACT. In Cork, Dr Dunphy said he became involved in the controversial field because his sister suffers from multiple sclerosis and was faced with a long waiting list for the procedure at the ACT clinic in Rotterdam. Most UK patients to date have travelled to Holland for their injections. The Rotterdam clinic, run by Dr Robert Trossel, who carries out his initial consultations in Harley Street, London, is also under investigation by the Dutch authorities. However, the clinic has been allowed to stay open during the investigation as there have been no reports of anybody suffering harm.

Denying some scientists' claims that there is little or no evidence that these cells can influence the course of neurological disease, Dr Dunphy commented 'we know they work. These cells hone into the central nervous system. They repair damaged tissue. You just have to get them to the right place'. The Department of Health in the UK says that despite the fact that the government is investing in stem cell research the science is still in the very early stages of development. In a statement they advise, 'We would urge caution against seeking treatment or procedures that have not been subjected to rigorous clinical trials and assessment of safety and potential efficacy. Patients with multiple sclerosis are advised to speak to their consultant about their best treatment options'.