The science community on the island of Ireland has broken new ground with the announcement of the country’s first stem cell manufacturing facility in NUI Galway.
The Centre for Cell Manufacturing Ireland (CCMI) has been in development for the last 10 years, with help from the Regenerative Medicine Institute (REMEDI), also in NUI Galway, which has been working to develop new therapies through the testing of stem cells to impact many different areas of unmet medical need.
Stem cells are considered ‘blank’ cells with no particular function, known as undifferentiated, which can then be modified by scientists to perform a particular function, such as being created to form red blood cells to carry oxygen.
Through the creation of these new ‘differentiated’ cells, there can be considerable potential for the regeneration of replacement cells, or even whole new body parts.
As the study and testing on stem cells has proven controversial in the past, the centre has now been finally granted accreditation to manufacture and now plans to supply stem cells for use in clinical trials following regulatory approval arising from pre-clinical data generated at REMEDI.
First expected trial
There are already plans for the first trials and research project using the CCMI-produced stem cells.
With the collaboration and funding provided by Science Foundation Ireland (SFI) and the Health Research Board, the indigenously manufactured cells will investigate the safety of using mesenchymal stem cells (MSCs), isolated from bone marrow, for the treatment of critical limb ischemia, a common complication associated with diabetes and which can often result in limb amputation.
Along with the medical potential for the centre, the CCMI will also be looking to offer its services to industry and local business to avail of its top-class facility, including offering a custom ATMP (advanced therapeutic medicinal product) manufacturing service to industry and a clean room leasing service to Irish SMEs who often have difficulty in procuring clean room space.
The financial benefits for such research are considerably lucrative. Last year alone, revenue from regenerative medicine products was about US$1.3bn while nearly US$1.4bn was invested in companies in this space last year, as well.
Speaking at the launch, Prof Tim O’Brien, director of the CCMI, said: “The presence of this facility in Ireland positions us well to develop new therapies for a broad array of clinical problems 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.”