The VISICORT project has reached an exciting milestone having recently received regulatory and ethical approval to proceed with the first clinical trial of a cell therapy in high-risk corneal transplantation.
To prepare for the launch of the trial, Prof Matthew Griffin, Prof Thomas Ritter, Dr Siobhan Gaughan and Ms Aoife Duffy of NUI Galway, Ireland and Mr. Peadar Mac Gabhann of Biostór Ireland Ltd. visited the Charité Research Organization (CRO), in Berlin on Thursday 28th February 2019 (see picture) The meeting was hosted by the CRO clinical trial team of Dr Andreas Hüser, Dr Rita Hertrampf, Ms Juliane Schnorr, Dr Maximilian Posch and Ms Jeanette Lehmann and by Prof Uwe Pleyer of the Department of Ophthalmology, Charité University Medical Centre, who will be the principal investigator for the trial.
The VISICORT trial will be a Phase 1B clinical trial to test the safety and feasibility of intravenous allogeneic mesenchymal stromal cells (allo-MSC) as an immunotherapy for patients receiving a second or greater full-thickness corneal transplant who are at high risk of rejection. If the trial demonstrates that allo-MSC therapy is well tolerated in high-risk corneal transplant recipients, it will open the door to a Phase 2 trial to more clearly test its potential to reduce the occurrence of rejection and promote the long-term survival of repeat corneal transplant.
During the meeting, the VISICORT partners discussed and agreed on many of the organisational details of the trial and developed a time-line for allo-MSC manufacture and patient enrolment over the next year. The VISICORT clinical trial team are looking forward to meeting up again for further discussions with the entire consortium at a Plenary Meeting which will be held in Galway on Thursday 14th and Friday 15th March 2019.
For more information, visit www.visicort.eu
VISICORT has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 602470. The material presented and views expressed here are the responsibility of the author(s) only. The EU Commission takes no responsibility for any use made of the information set out.