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| |  Biosynthetic Corneas Restore Vision, Nerve Growth OTTAWA, Ontario -- August 25, 2010 – Results from a 2-year clinical study demonstrate that surgical implantation of biosynthetic corneas formulated with a recombinant human type III collagen (rhCIII) can help regenerate and repair damaged eye tissue and improve vision in patients with corneal damage. The results, from an early phase clinical trial, are available in the August 25 issue of Science Translational Medicine. "This study is important because it is the first to show that an artificially fabricated cornea can integrate with the human eye and stimulate regeneration," said senior author May Griffith, PhD, Senior Scientist, Ottawa Hospital Research Institute; Professor, the University of Ottawa; and Professor, Regenerative Medicine, and Director, Integrative Regenerative Medicine Centre, Linköping University, Linköping, Sweden. "With further research, this approach could help restore sight to millions of people who are waiting for a donated human cornea for transplantation." Globally, diseases that lead to clouding of the cornea represent the most common cause of blindness. More than a decade ago, Dr. Griffith and her colleagues began developing biosynthetic corneas in Ottawa, Canada, using collagen produced in the laboratory and moulded into the shape of a cornea. After extensive laboratory testing, Dr. Griffith began collaborating with Per Fagerholm, MD, Professor of Ophthalmology, Linköping University, to provide the first-in-human experience with biosynthetic cornea implantation. Together, they initiated a clinical trial in 10 Swedish patients with advanced keratoconus or central corneal scarring. Each patient underwent surgery on one eye to remove damaged corneal tissue and replace it with the biosynthetic cornea made from synthetically cross-linked recombinant human collagen. Over 2 years of follow-up, the researchers observed that cells and nerves from the patients' own corneas had grown into the implant, resulting in a "regenerated" cornea that resembled normal, healthy tissue. Patients did not experience any rejection reaction or require long-term immune suppression, which are serious side effects associated with the use of human donor tissue. The biosynthetic corneas also became sensitive to touch and began producing normal tears to keep the eye oxygenated. Vision improved in 6 of the 10 patients, and after contact lens fitting, vision was comparable to conventional corneal transplantation with human donor tissue. "We are very encouraged by these results and by the great potential of biosynthetic corneas," said Prof. Fagerholm. "Further biomaterial enhancements and modifications to the surgical technique are ongoing, and new studies are being planned that will extend the use of the biosynthetic cornea to a wider range of sight-threatening conditions requiring transplantation." This research was supported by grants from the Canadian Stem Cell Network, the Swedish Research Council and County of Östergötland, and a European Union Marie Curie International Fellowship. Initial work in developing the biosynthetic corneas was supported by the Natural Sciences and Engineering Research Council of Canada and the Canadian Institutes of Health Research. Recombinant human collagen type III used in formulating the biosynthetic corneas for the clinical study was provided by FibroGen, Inc., San Francisco, California. SOURCE: Ottawa Hospital Research Institute
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