The project is organised in eight work packages as illustrated in the following figure:
WP1 – Project Management
The aim of WP1 is to carry out management, coordination, quality assurance and reporting activities necessary to implement project management structures and procedures, to ensure effective implementation of the project tasks and provision of deliverables, milestones, and budget according to the Grant Agreement and Consortium Agreement and to ensure efficient communication between the partners, with the EC and outside the consortium.
WP2 – Bioengineered Porcine Collagen Scaffolds
Here, a novel stromal replacement scaffold will be first validated in a preclinical model, followed by regulatory and ethical approvals to implant the scaffold in blind patients in a clinical pilot study to be conducted in Sweden.
WP3 – Fish scale based collagen scaffold
The fish scale based ologen™ Biocornea is developed as an alternative to the temporary cadaveric corneas that do not meet all the criteria of transplantation grade tissue. In this WP, the Biocorneas will be tested for efficacy in temporary sealing of the eye globe, in a pig transplantation model of emergency corneal trauma. The favourable outcome of the pig study will form the basis for the “first in man” clinical trial.
WP4 – Establishing GMP-compliant endothelial cell sheet transplantation
Ex-vivo expanded sheets of endothelial cells will be prepared by optimizing culture conditions and substrates, and will be validated in preclinical transplantation model. A roadmap for GMP compliance of the cell sheet preparation will be provided.
WP5 – Phase II multicenter trial for limbal epithelial stem cell transplantation
Ex-vivo cultivated limbal epithelial cell sheets will be validated in a Phase II multi-center trial in Belgium. Novel imaging techniques will be used to improve donor tissue harvesting and to link patient outcomes with specific characteristics of the donor tissue both pre- and postoperatively.
WP6 – Imaging and regression of pathologic corneal lymph vessels to regenerate corneal (lymph)angiogenic and immune privilege
Restoration of a functioning corneal immune privilege is critical for the success of surgical interventions such as stem cell and corneal transplantation. Here, novel techniques and agents will be evaluated for efficacy in regressing blood and lymph vessels in the cornea. New imaging modalities will be developed for assessing the immune status of the cornea prior to and post intervention.
WP7 – Neuroregeneration and corneal sensitivity
Maintenance or regeneration of a neuro-protective environment is critical for the survival of transplanted cells and for normal cell function and turnover in the cornea. Novel neuroprotective agents will be evaluated for efficacy of inducing nerve regeneration and restoration of corneal nerve function and sensitivity to external stimuli.
WP8 – Dissemination and Exploitation
The objectives of WP8 are to disseminate and communicate all relevant project results and activities to the scientific and medical community, patient associations, and Key Opinion Leaders within the cornea research community, in academia, and industry – in the EU and globally, to develop an appropriate dissemination and communication strategy, to develop and maintain an exploitation and intellectual property strategy and to ensure that the results and collaborations within the ARREST BLINDNESS network are extended to all relevant cornea research and transplant centres in the EU during the course of the project.