Arthritis will be a key focus area for a new manufacturing plant in Galway, the first in Ireland to be approved to culture stem cells for human use.
The Irish Medicines Board issued the licence for the pioneering facility, based in NUI Galway, which aims to tackle a number of conditions as well as osteoarthritis, including heart disease, diabetes and associated conditions.
The centre, which has been developed by researchers at NUIG’s regenerative medicine institute, is one of a select few in Europe authorised for stem cell manufacture,
Stem cells work to repair the body and can be isolated from tissues such as bone marrow and fat, and cultured in laboratory settings.
More controversially, embryonic stem cells have been highly valued for their ability to turn into any type of cell in the body, but scientists can now use reprogrammed adult skin cells to create a stem cell that is very similar to embryonic versions.
Minister of State for Research and Innovation Seán Sherlock is launchjing the centre today with the facility’s new director Prof Tim O’Brien.
Mr O’Brien said that the stem cells must be grown in the laboratory to generate sufficient quantities, following their isolation from the bone marrow of adult donors, and the facility will help Ireland to develop therapies for a broad range of clinical problems, such as arthritis, which do not have effective treatments today.
“It will also allow us to translate discoveries from the basic stem cell research programme led by Prof Frank Barry at the Science Foundation Ireland-funded REMEDI to the clinic, and to be competitive for grant funding under the Horizon 2020 programme of the EU,” he said.
“We can only engage in clinical trials with clinical authorisation from the IMB and approval from the hospital ethics committee, and we are currently seeking such approval for clinical trials,”he said.
“The license to manufacture is an essential pre requisite to seek permission to undertake clinical trials. The license certificate must be included with the clinical trial authorisation application.”
NUIG president Dr Jim Browne said the centre develops Galway’s role as a “med tech hub of global standing”, while Irish Medical Devices Association board member John O’Dea has pointed to the lucrative revenue to be earned from regenerative medicine products, valued at about €1.3 billion in 2013 and with a 40 per cent sales growth last year.
Some 70 per cent of pharmaceutical companies are working on regenerative medicine therapies – an area described as a crossover between biology and engineering – and NUIG estimates that there are over 1,900 cell therapy clinical trials under way globally.