The main goal of ARREST BLINDNESS is to develop and validate more effective advanced regenerative and restorative therapies to treat the loss of corneal transparency so that it does not result in blindness. Specifically, the objectives are:
- To validate tissue-engineered GMP-compliant scaffolds based on natural materials
To address the global shortage of human donor cornea tissue, scaffolds engineered from natural collagen will be validated pre-clinically and in first-in-man Phase I clinical studies, to obtain approvals for broader Phase II studies and CE-mark studies. This objective will be addressed in WP2 and WP3.
- To validate and optimize new GMP-compliant cell-based therapies
There is currently a lack of standardized, approved cell-based therapies for reconstruction of the cornea. Standardized and GMP produced human corneal endothelial and epithelial stem cell sheets will be evaluated in pre-clinical and Phase II transplantation studies, respectively, to obtain regulatory approvals for Phase I studies and for medical insurance reimbursement to patients. This objective is addressed in WP4 and WP5.
- To validate new molecular agents and drug delivery approaches for restoring the neural and immune environment
There is also a lack of approved therapies for the high-risk situation of a vascularized immune-compromised cornea or a neurotrophic deficit in the cornea. Preclinical studies and a pilot clinical study will be conducted to assess safety and efficacy of new molecular therapies targeting these high-risk transplantation situations. This objective will be addressed by WP6 and WP7.