Approval was obtained from the HPRA in 2014 to carry out a phase 1b, open label, uncontrolled, non-randomised dose-escalation CLI Stem Cell Trial.
This study will examine the safety of intramuscular autologous transplantation of escalating doses of mesenchymal stem cells to patients with no option critical limb ischemia (CLI).
Patient enrolment has commenced and CCMI are currently manufacturing batches for this trial and this will continue on a phased basis over a two year period as the patients are selected.
ADIPOA-2 Clinical Trial
Prof. Frank Barry - ADIPOA 2
Funding has been granted by the EU’s Horizon 2020 research funding program to carry out a large-scale Phase 2 clinical trial to treat osteoarthritis in the knee.
Osteoarthritis (OA) is an incurable and debilitating disease. It has been identified as the world’s eleventh highest contributor to disability and affects over 70 million Europeans. There is currently no treatment to prevent progression of the disease.
ADIPOA-2 will build on the work of ADIPOA to deliver a large-scale clinical trial in regenerative medicine for OA. The purpose of the project is to design and implement a phase IIb study to assess the safety and efficacy of autologous (patient-derived) ACSs in the treatment of advanced OA of the knee. The cells will be prepared from samples of adipose tissue harvested from patients by lipoaspiration.
It is a randomised clinical trial across 10 hospitals in Europe and involving 150 patients.
CCMI is currently manufacturing batches for the Galway Clinical Site and these are being used to treat osteoarthritis in patients. Recruitment of patients is currently active.
Further information on the clinical trial can be viewed at http://adipoa2.eu/
Prof’s Tim O’ Brien and Matt Griffin – NEPHSTROM
Horizon 2020 EU funding has been granted to Orbsen Therapeutics to carry out a four year project NEPHSTROM, which will study the use of next-generation stem cell therapies to combat diabetic kidney disease.
Orbsen Therapeutics use patented technology to purify stromal (stem) cells, and the trial is currently treating patients with diabetic kidney disease as part of the first-in-man trials.
The trial is taking place in Galway, Belfast, Birmingham and Bergamo, using 48 patients with the hope of the treatment slowing down or eradicating the patient’s kidney disease.
The research project is a collaboration with 11 European partners and builds on the EU-funded project REDDSTAR which uses stromal cells to treat diabetes mellitus.
CCMI are currently manufacture stem cell batches as part of this project.
More information on the trial is avaiable to view on http://nephstrom.eu/
The Centre for Cell Manufacturing at NUI Galway is a custom-built licensed centre designed to manufacture stem cells for use in human clinical trials. This is the first centre of its kind on the island of Ireland.
National University of Ireland