The Irish Medicines Board-licensed facility was opened in last month by Minister Seán Sherlock who said it positions Ireland as a global player in the regenerative medicine field.
The 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.
The facility will be part of plans for the first clinical trial using CCMI- manufactured stem cells which is being funded by the Health Research Board and Science Foundation Ireland. The trial 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.
MSCs must be grown in the laboratory to generate sufficient quantities following their isolation from the bone marrow of adult donors.
Minister of State for Research and Innovation Seán Sherlock said: “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.”
Sherlock also said “the facility will play a key role in ensuring REMEDI’s continued success in EU funding initiatives, in particular Horizon 2020”.
Ireland’s government, through SFI, will work to ensure that Ireland maximises its participation in the Horizon 2020 programme, which is the biggest EU Research and Innovation programme ever with nearly €80 billion of funding available over 7 years (2014 to 2020) – in addition to the private investment that this money will attract.
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.