Protectively Decellularized Porcine Cornea versus Human Donor Cornea for Lamellar Transplantation

Decellularization can reduce the immune barrier of xenotransplantation, but tissue swelling‐caused structural and functional damage remains unsolved, including corneal transparency loss after decellularization. Here, a protective decellularization strategy is developed for the preparation of decellularized porcine cornea (DPC), in which corneas are treated by detergent and endonuclease in the protective medium with 50 mmHg colloid osmotic pressure. A nonrandomized open‐label trial is conducted to evaluate the clinical outcome of lamellar transplantation with DPC versus human donor cornea (HDC) as grafts. Through the protective corneal decellularization, major xenoantigen DNA and α‐gal are efficiently removed, while corneal original structural and transparency characteristics are preserved. Among the 23 patients with DPC transplantation for 12 months, 22 grafts survive without ulcer recurrence or immune rejection, 1 graft demonstrate melting. Compared with HDC grafts, DPC grafts showed early suture loosing, but no complication is observed with timely removal. The epithelial regeneration rate, graft transparency restoration, best‐corrected visual acuity improvement, and mechanical properties achieve equivalent levels compared with that of HDC grafts. Collectively, the results suggest that the porcine cornea through protective decellularization may provide an effective “off‐the‐shelf” substitute of globally‐shortened human donor tissue for lamellar transplantation. The porcine cornea after decellularization represents a promising alternative source to overcome the shortage of human donors. Here, a protective decellularization strategy is designed for the porcine cornea without jeopardizing the ultrastructural integrity and transparency function. Clinical transplantation of the protectively decellularized porcine corneas in patients for 12 months achieves an equivalent outcome to that with human donor corneas.