A new porcine skin based collagen scaffold was developed to overcome deficiencies of previous attempts at tissue-engineering the bulk of the corneal tissue. This device has been tested clinically in patients outside the EU, using a newly developed intrastromal implantation procedure, which is minimally invasive compared to the standard more invasive techniques in use today. By the end of the Project it is expected that Clinical data with this device will enable larger-scale multi-center randomized studies to be conducted within the EU, to gather more Clinical data in support of a CE-mark application. Also within the Project, a fish scale collagen-based device, designed as a temporary emergency corneal patch, has been implanted in seven patients in a first-in-man trial, and by the end of the Project the results will indicate whether this technology can meet the great demand for an off-the-shelf solution to preserve vision in emergency corneal rupture cases, often seen in traumatic injury, for example in small remote clinics and in locations where other transplantation options or infrastructures are unavailable. Both these devices are defining the state-of the art in the field of corneal replacements, where no similar technologies exist. By the end of the project, these devices have the potential to alleviate the high demand and long waiting times for human donor corneas, which today keeps millions of cornea-blind people from being productive members of society.
While stem cell transplantation can treat corneal blindness, the procedure still carries high risks of tissue rejection and transplant failure. During the reporting period, a multi-center clinical trial of limbal stem cell transplantation using a GMP xenogenic-free process has applied new advanced stem cell imaging and real-time surgical imaging tools to optimize tissue harvesting and surgery, to improve patient outcomes. The outcomes of surgieries in all patients in the trial have been reported and final follow-up data is being analyzed. By the project end, these procedures have the potential to set a best-practice standard for this type of surgery.
A new non-invasive diagnostic imaging device for detecting corneal lymphatics has been developed for management of high risk vascularized corneas. The device based on optical coherence tomography, has been tested in preclinical models and in the first human subjects with positive results, with the device having received CE-mark and entering clinical studies. The studies have been completed and represent the first use of this technology in the setting of corneal transplantation. Combined with this innovation, new angio-regressive therapies targeting the immune response of the cornea have been tested with positive results. These innovations have the potential to prevent corneal graft failure. Each surviving corneal transplant saves €170,000 in long‐term health care costs, for a total savings of €6.8B if the current European transplantation rate of 2% could be doubled.
Finally, a new neuro-regenerative agent has been discovered for use in the cornea, and has shown promising results in models of corneal surgery and corneal disease. Combined with this new agent, a biomaterial-based slow release drug delivery technology was developed and validated in a relevant preclinical model, paving the way for further applications for drug development and first human clinical studies.
