GP provided stem-cell treatment in clinic until change in EU rules

Background: Dr John Dunphy began providing the controversial stem-cell treatment at his clinic in Carrigaline two to three months ago, using stem cells provided by Swiss-based company Advanced Cell Therapeutics.

According to its website, Advanced Cell Therapeutics is a biotech company pioneering the advancements and therapeutic applications of cord blood stem-cell therapy which carries out treatments at 12 international locations.

The website lists these locations, which in Europe include Switzerland, Holland, Germany and Spain but makes no mention of having any clinic in Ireland. All stem-cell lines are derived from human umbilical-cord blood and have been third-party tested for type, count, viability, purity and safety in accordance with the American Association of Blood Bank standards, the website says.

The company also says that the proprietary protocols which it utilises to generate the cord blood stem cells have been used safely and effectively over the last four years in over 500 treatments in 52 different conditions.

While stem-cell treatment is unlicensed in Ireland, Dr Dunphy was free to administer it as a registered medical practitioner if he felt it was an appropriate treatment for a particular patient.

However, Dr Dunphy has ceased providing the treatment since April 7th last when Ireland implemented the EU Tissues and Cells Directive which was approved by EU governments and the European Parliament on April 7th, 2004, with a two-year period for compliance.

The directive requires EU member states to set up a competent authority to inspect and accredit both public and private tissue-banking establishments to ensure that staff engaged in procuring donor tissues and other tissue banking activities are properly trained.

According to Dr Dunphy, the Irish Medicines Board has been appointed as the competent licensing authority in Ireland and he has already applied to the board for a licence to store stem cells at his clinic in Carrigaline to allow him continue with his treatments.

"It's basically licensing any place that stores human tissue in the same way that it would license a blood bank - I'm not storing tissues in that sense but I'm still caught by this legislation, as I understand it, unless I can get legal advice to the contrary.

"Even though the cells arrive on my premises in dry ice and are only on my premises for four to six hours, I am still caught by this requirement. I can still administer the cells but I must have a licence from the IMB to store them, so everything is stopped at the moment."

The entire area of stem-cell treatment has proven highly controversial and the revelation last month that Dr Dunphy was providing unlicensed stem-cell treatment at his clinic in Carrigaline prompted expressions of concern from many medical experts.

Consultant neurologist at Cork University Hospital Dr Brian Sweeney, a member of the Irish Institute of Clinical Neuroscience, expressed serious concerns last month to The Irish Times at reports of the treatment being provided in Cork to people suffering from MS.

"There is no scientific evidence that this particular treatment, which supposedly involves 'stem cell' material injected into the vein and which is then supposed to travel to the brain and repair the damaged caused by MS, is in any way effective or safe," said Dr Sweeney.