A comprehensive clinical history and examination will be performed on each subject on the day of surgery and at specific time-points post-CT (before, at surgery, 1, 6, 12, 24, 36 months after surgery). In addition, in case of inter-current events such as graft rejection, graft failure, and other specified complications (non-healing epithelial defects, broken sutures, keratitis, uveitis, glaucoma, vessel in-growth), data will be entered into the database as well. All clinical details will be entered into the secure central database.
The data and samples collected in the prospective clinical study are of importance to the clinical trial as these patients will serve as a “historical” control group for comparison to stem cell recipients for the clinical trial patient group. D4.3 (WP4) will be a report of multi-time-point peripheral blood immune assays, transcriptomic and proteomic profiles of prospectively followed human FT- and PL-CT recipients. D5.2 (WP5) is the development of biomarker panels and immunoassays (and methods of detection) which will reliably diagnose or predict risk for rejection and other adverse events in most CT recipients.