Clinical Trials

Prof. Tim O’ Brien – Critical Limb Ischemia (CLI)

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.

Upcoming Clinical Trials

 

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.

This will be a randomised clinical trial across 10 hospitals in Europe and involving 150 patients.

Preparations are now underway in CCMI to introduce the manufacture of Verification Stem Cell Batches and these batches will support the application process for the approval of this multicentre clinical trial across the EU.

CCMI will manufacture cell batches for centres in the UK, Dublin and Galway and these will be used to treat osteoarthritis in patients.

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, which by 2016 they expect to begin injecting into patients with diabetic kidney disease as part of the first-in-man trials. 

The trials will take 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 will manufacture stem cell batches as part of this project.

VISICORT (Prof Matthew Griffin and Dr Thomas Ritter)                        

A more long term project is “VISICORT” (Adverse Immune Responses and their Prevention in Corneal Transplantation) which is a five-year project and is jointly coordinated by Prof Matthew Griffin and Dr Thomas Ritter in partnership with 11 other academic and industry-based partners from France, Germany, Denmark and the UK.

The final year of the project will involve a clinical trial testing the usefulness of stem cells in corneal transplant.

CCMI will manufacture stem cell batches for this project.