Ireland’s First Human Use Stem Cell Manufacturing Facility at NUI Galway
The Centre for Cell Manufacturing Ireland (CCMI) at NUI Galway is the first ever facility on the island of Ireland to receive a licence from the Irish Medicines Board to manufacture culture-expanded stem cells for human use.
This facility in Galway, opened today by Minister Seán Sherlock, positions Ireland as a global player in the regenerative medicine field and is a significant development for the med tech sector as a whole.
There are many human diseases which have either inadequate or no effective treatments, and since 2004 researchers based at the Regenerative Medicine Institute (REMEDI) in NUI Galway have been working to develop new therapies to impact many different areas of unmet medical need.
To develop any new human therapy, the treatment must first be tested for safety and effectiveness in a series of rigorous clinical trials. Over the past number of years REMEDI has developed the Centre for Cell Manufacturing Ireland which is a custom-built facility designed to expand stem cells for use in human clinical trials. Now it has been successfully accredited, the Centre for Cell Manufacturing Ireland plans to supply stem cells for use in clinical trials following regulatory approval arising from pre-clinical data generated at REMEDI.
Today’s announcement coincides with plans for the first clinical trial using CCMI- manufactured stem cells which is being funded by the Health Research Board and Science Foundation Ireland. It 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. MSCs must be grown in the laboratory to generate sufficient quantities following their isolation from the bone marrow of adult donors.
President of NUI Galway Dr Jim Browne said: “developing Galway’s role as med tech hub of global standing, the Centre for Cell Manufacturing Ireland captures NUI Galway’s commitment to bring bold ideas to life. Innovation can bridge the gap between patient and provider and meet the needs of industry and the wider society in a balanced way.”
Minister of State for Research and Innovation Seán Sherlock said that “The Centre for Cell Manufacturing Ireland is clear evidence of the potential benefits offered by this Government’s substantial investment in applied research. Stem cell technology, developed in the first instance to help patients with diseases such as diabetes, arthritis, heart disease and critical limb ischemia, can also create sustainable growth and jobs in Ireland’s smart economy by making researchers’ visions a reality.”
The Minister also said “the facility will play a key role in ensuring REMEDI’s continued success in EU funding initiatives, in particular Horizon 2020”. The Minister added that the Government, through SFI, will work to ensure that Ireland maximises its participation in the Horizon 2020 programme.
Speaking at the launch, Professor Tim O’Brien, Director of the Centre for Cell Manufacturing Ireland 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 Professor 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.”
John O’Dea, Board member of the Irish Medical Devices Association (IMDA) said “revenue from Regenerative Medicine products was approximately $1.3bn in 2013, with sales growth of 40% in 2013 alone. Nearly $1.4bn was invested in companies in this space in 2013. The Centre for Cell Manufacturing Ireland is a key step in the demonstration of national competence in this space and I look forward to seeing its continued growth to assist in developing the skillsets and techniques that will be needed to embrace the new manufacturing opportunities that this exciting area will bring.”
In addition to stem cell manufacture, Centre for Cell Manufacturing Ireland (CCMI) are offering a custom ATMP (advanced therapeutic medicinal product) manufacturing service to industry and also a cleanroom leasing service to Irish SMEs who often have difficulty in procuring cleanroom space.