A Swedish team has successfully implanted biosynthetic corneas in a small human trial, in a clinical study first.
A Swedish team has successfully implanted biosynthetic corneas in a small human trial, in a clinical study first.
Professor of ophthalmology at Linkoping University, Per Fagerholm and study co-leader May Griffith removed diseased tissue from the corneas of 10 patients and replacing them with biosynthetic implants. The process uses recombinant human collagen, synthesized in the laboratory to mimic human tissue.
The patients were monitored for two years following surgery and the scientists found that the cells and nerves from 9 of the 10 subjects regrew completely and packed themselves into the implant which produced a 'regenerated' cornea. The authors said: The biosynthetic implants remained stably integrated and avascular for 24 months after surgery, without the need for long-term use of the steroid immunosuppression that is required for traditional allotransplantation. The also confirmed: Corneal reepithelialization occurred in all patients, although a delay in epithelial closure as a result of the overlying retaining sutures led to early, localized implant thinning and fibrosis in some patients. The tear film was restored, and stromal cells were recruited into the implant in all patients. Nerve regeneration was also observed and touch sensitivity was restored, both to an equal or to a greater degree than is seen with human donor tissue. Vision at 24 months improved from preoperative values in six patients. With further optimization, biosynthetic corneal implants could offer a safe and effective alternative to the implantation of human tissue to help address the current donor cornea shortage.
The full study is published in Science Translational Medicine .