Second Reporting Period completed

A cornerstone of ARREST BLINDNESS is four clinical studies, each addressing a different cause of blindness using advanced technologies to regenerate and restore tissue. During the second of three project reporting periods, a tissue-engineered porcine collagen implant was tested pre-clinically with 6-months follow up, with positive results subsequently reported to the regulatory authority in Sweden. Ethical approval for a first clinical study was granted in Sweden and regulatory approval is currently pending. Another advanced device, an emergency corneal patch made from fish scale collagen, was implanted in five patients in a first-in-man study in Germany. The patch functioned as designed in all cases, and an additional trial site has been instated. Regulatory engagement by device manufacturer in The Netherlands is ongoing, in preparation for further Product approvals.

A Phase II clinical trial of a limbal stem cell advanced therapy medicinal product is underway in Belgium and over two-thirds of patients have been recruited. New quality control measures and advanced preoperative and intra-operative corneal imaging have been integrated into routine practice to improve the success rate of the stem cell transplantation procedure. Ethical aspects of living donation of corneal tissue have been explored with the project Ethical Advisor and will form the basis of a set of recommendations. Furthermore, a tool for consistent grading of limbal stem cell deficiency has been developed to aid in reporting of oucomes for this type of advanced surgery.  Additionally a new high-resolution optical coherence tomography system has been integrated into a standard ophthalmic slit lamp microscope, to allow the possibility of immune imaging of the ocular surface for improved transplantation prognosis. The device has received CE-mark and will be used in a Clinical study in high-risk corneal transplantation, which is now recruiting patients in Germany. The study aims to test new preclinically validated approaches for restoring corneal transparency after loss of immune privilege and ingrowth of pathologic blood and lymph vessels into the cornea.

Several SME partners are developing new medical device and drug delivery technologies, which provides access to new markets thereby stimulating the growth of these companies. Another novel regenerative agent, a biologic nerve regeneration factor, has been evaluated for the promotion of epithelial wound healing, nerve regeneration and tear film and blink restoration after corneal injury in preclinical models in Spain. Positive results in these models are being followed by further in vivo studies in a relevant corneal transplantation model, further using a novel hydrogel-based drug delivery device manufactured in Sweden.

Finally, a new advanced therapy of endothelial cell sheets for endothelial transplantation is being validated for GMP compliance in Austria while in parallel this cell sheet has been optimized in terms of cell culture conditions, substrate material and surgical implantation technique in The Netherlands. The cell sheet is being validated in a preclinical study being conducted in Denmark.