Lamellar keratoplasty treatment of fungal corneal ulcers with acellular porcine corneal stroma

Abstract

The fundamental problem of corneal transplantation is a severe shortage of donor tissues worldwide, resulting in approximately 1.5 million new cases of blindness annually. To explore an alternative to donor corneas, we conducted a clinical study in which implanted acellular porcine corneal stromas (APCSs) replaced the pathologic anterior corneas in 47 patients who had experienced fungal corneal infections. Subsequently, we demonstrated the safety and efficacy of APCSs in human keratoplasty for a minimum follow-up period of 6 months, during which time no recurrence of infection was observed. All corneal ulcers healed with the return of neovascularization. In addition, our results indicated that epithelialization occurred in all APCS grafts except four grafts; for these four, the grafts dissolved to varying degrees. Furthermore, most porcine grafts (n = 41) gradually became transparent without rejection, and an improvement of more than two lines in best corrected visual acuity (BCVA) was achieved in 34 eyes (∼72%). Finally, no patients showed any severe adverse reaction or any significant change in postoperative systemic safety indicators. Thus, we concluded that APCS grafts are safe and efficacious during lamellar keratoplasty in treating corneal fungal ulcers and potentially for other clinical diseases.

Keywords: artificial organs / support devices; bioengineering; clinical research / practice; clinical trial; corneal transplantation / ophthalmology; regenerative medicine; tissue / organ engineering; xenotransplantation.