HONOLULU, Aug. 31 /PRNewswire/ -- Eyegenix™, the ophthalmic division of Cellular Bioengineering, Inc. (CBI), announced today that the results of a pilot clinical trial using a synthetic cornea for which Eyegenix™ holds the exclusive global license for transplantation were published in the peer-reviewed journal, Science Translational Medicine (Volume 2, Issue 46, August, 25, 2010). The publication reported two year results of a clinical trial that transplanted bioengineered corneas into 10 patients who were visually impaired on the transplantation wait list. All patients regained nerve sensation and tear formation without the prolonged use of anti-rejection drugs, and six of the patients improved to best corrected post-operative acuity of 20/40 with contact lenses. As a group, this improvement was comparable to a cohort treated with traditional human allograft transplant.
Eyegenix™ has the exclusive worldwide commercial corneal transplantation rights to this biosynthetic material, which holds the potential promise to cure blindness in the estimated 10 million people who suffer from corneal disease but have no access to a donor for transplant. Invented at the University of Ottawa and the National Research Council of Canada by Drs. May Griffith, David Carlsson and their colleagues, it is under collaborative development by CBI / Eyegenix™, the University of Ottawa Health Research Institute, and Dr. Per Fagerholm from University of Linkoping, Sweden, the surgeon who conducted the transplants and lead author of the publication.
Dr. Francis W. Price, Jr., founder and President of the Cornea Research Foundation, who was not involved in the research, told the Los Angeles Times, "This is a huge breakthrough. It still has to go through additional studies... but it shows a lot of promise." In a statement to the Associated Press regarding the published clinical study results, Dr. Alan Carson, cornea transplant chief at Duke University's eye center, who has not been involved with the research, asserted, "I characterize this work as a major advance in the direction that we need to go."
Although corneal transplantation is a successful procedure that is performed more often than all other types of organ transplants combined, it is only able to impact less than 2% of patients with corneal blindness worldwide due to a lack of donors. The material under exclusive license to Eyegenix™ is unique in its approach of replacing a human donor with a completely synthetic, transplantable cornea designed to promote tissue regeneration, which can be an off-the-shelf solution to a huge access problem.
"CBI is extremely proud to be part of this effort," said Mark Mugiishi, M.D., Medical Director of CBI. "Our inventors, scientific and development team members, and clinical champions have emerged from all parts of the world. We have positioned ourselves as forerunners in the race to bring vision back to 10 million blind people in the world, and that's something all of us are incredibly passionate about."
This unique tissue scaffold uses biosynthetic collagen, produced by FibroGen Inc. of San Francisco, California, to encourage cells from the recipient to grow into the graft and mimic natural healing.
Eyegenix™ / CBI is currently making preparations for expanded trials and are completing certified manufacturing facilities for large scale clinical production, both for use in the next set of clinical trials and for eventual global patient use. "Certifying our manufacturing processes and initiating a large scale global clinical trial is our next big step," said Eyegenix™ Chief Operating Officer Tony Lee. "We are looking forward to manufacturing a large supply of artificial corneas to meet the demand of restoring vision around the world."
About Cellular Bioengineering, Inc. (CBI) and Skai Technologies, LLC
CBI and its sister company Skai Technologies, LLC transform novel ideas from the research labs to become disruptive technologies and products with global impact. The companies have multiple operating divisions including:
- Eyegenix™, which owns the global commercial rights to the artificial cornea technology reported above and holds the promise of returning sight to people worldwide who are blind from corneal disease through transplantation.
- CBI Polymers LLC manufactures a family of DeconGel™ products for the cost effective and environmentally sustainable decontamination of radioactive, nuclear, and chemical spills, and with additional applications in industrial cleaning and environmental remediation.
- TruTag Technologies LLC has developed TruTags™, an edible, nanoporous silica microtag that can be used for on-dose authentication of pharmaceuticals and nutraceuticals, protecting consumers from the health risks of counterfeit medicine. TruTags™ can also be used to authenticate implantable medical devices, consumer electronics, industrial parts and components, luxury goods, textiles and currency.
CBI, DECONGEL, EYEGENIX, SKAI, TRUTAG and INVENT. DISRUPT. INSPIRE. are trademarks of Cellular Bioengineering, Inc., Skai Technologies, LLC and their affiliated companies. Copyright © 2010 Skai Technologies, LLC. All rights reserved. All other trademarks are property of their respective owners.
SOURCE Cellular Bioengineering, Inc.