Failure to legislate ‘will hurt research’

Even though stem cell manufacture has just been licensed in this country, the Government’s ongoing failure to legislate in this area means pharmaceutical giants will still be wary of investing here, according to an expert in stem cell therapy.

The Irish Medicines Board has just licensed a new facility, the Centre for Cell Manufacturing Ireland, to supply adult stem cells for use in research on arthritis, heart disease, diabetes and other conditions.

Once the stem cells are harvested from the bone marrow of adult donors, they are grown in the Galway laboratory to generate sufficient quantities.

The first clinical trial using these stem cells is being funded by the Health Research Board and Science Foundation Ireland and will investigate the safety of using mesenchymal stem cells (MSCs) isolated from bone marrow for the treatment of critical limb ischemia, a complication associated with diabetes which can lead to limb amputation.

John O’Dea of the Irish Medical Devices Association (IMDA) said the centre was a “key step”.

“I look forward to seeing its continued growth to assist in developing the skill sets and techniques that will be needed to embrace the new manufacturing opportunities that this exciting area will bring,” he said.

The centre, one of a handful in Europe authorised for stem cell manufacture, has been developed by researchers at NUIG’s regenerative medicine institute.

However, Dr Stephen Sullivan, chief scientific officer with the Irish Stem Cell Foundation warned all stem cell research operates at a pan-global level driven by big pharma and international equity firms and these players will only engage with researchers in countries where there is solid stem cell legislation in place. He welcomed the centre as a “first step” but said if Ireland is to compete at a top international standard, legislation remains necessary.

“This licensing isn’t enough. It isn’t enough to have an absence of prohibitory legislation, the absence of supportive legislation means Ireland, in many cases, cannot undertake international standard stem cell research. It is disingenuous to suggest that Ireland is not affected by this legal vacuum or that only work with some stem cell types is affected. What we are seeing here is capacity to contribute at an international level being sidelined due to Minister Sherlock and the Government failing to act on their promise in the programme for government: the promise to legislate for stem cell research,” he said.

However, Minister for Innovation Sean Sherlock strongly denied that this investment can only go so far without legislation.

“There is absolutely no reason why Ireland couldn’t be part of international stem cell research. There is no impediment at all to us leveraging the work being done by the new centre in Galway,” he said.

The centre’s director Prof Tim O’Brien also denied that lack of legislation would hamper research capabilities, saying this only applies to embryonic research and not adult stem cell research.