Our goal is to build on existing research to perfect a stem-cell manufactured “model” of the front of the human eye (called the “cornea”) that can be used as a tool to improve the safety of chemicals and consumer products, as well as a tool for researchers to study eye injuries.
Over 10 million people worldwide suffer from loss of sight due to their corneas becoming cloudy or opaque partly due to trauma and injury. Damage to the cornea by household products are involved in 125,000 eye injuries each year. Regulatory authorities in most countries require safety assessment of consumer products for potential eye injuries and commonly the “Draize” rabbit test their “gold standard” test. The Draize test determines the potential degree to which a substance damages the human eye by applying a substance in question directly in the eye of a rabbit. The Draize test is regarded by scientists as being flawed and by the public as cruel. Even with this limitation, alternative tests have not been effective as substitutes for the Draize test. Recently, top officials from the U.S. National Institutes of Health (NIH) and Environmental Protection Agency (EPA) announced an effort designed to expand the use of human cells to identify chemicals with toxic effects and therefore allow for non-animal-based laboratory models to gain a foothold towards becoming the new “gold standard.”
Large economic and health benefits will accrue to California through the completion of a living stem-cell-based model of the cornea as a research tool to study eye injury. It will provide a safer environment for California consumers and workers through more accurate eye safety testing of chemical and household consumer products. It will provide a laboratory model for researchers to study healing of the eye for clinical research. World-wide demand for such a product will provide manufacturing and employment opportunities for Californians and added income to California. Our goal is to generate a corneal tissue model created from human parthenogenetic stem cells. Parthenogenetic stem cells are created from unfertilized human eggs and have the same characteristics as standard human embryonic stem cells, including the ability to become other human tissues, but don’t generate a viable human embryo in the process. We will build upon existing discoveries and develop a parthenogenetic stem cell-based corneal tissue model that can be provided as a standardized research tool allowing measurement of eye injury. We will achieve this goal by causing the stem cells to divide into corneal tissue and provide this tissue in a form that can be used to test chemicals and consumer products. The model will be manufactured and quality-tested so it is consistent. We will test the model using known chemicals and consumer products to prove that the model works. If successful, our efforts will result in a superior model to measure human eye damage.
Statement of Benefit to California:
Large economic and health benefits will accrue to California through the completion of a living stem-cell-based model of the human eye (the cornea) as a research tool to study eye injury. It will provide a safer environment for California consumers and workers through more accurate eye safety testing of chemical and consumer products. It will provide a laboratory model for researchers to study healing of the eye for clinical research. World-wide demand for such a product will provide manufacturing and employment opportunities for Californians and added income to California. Finally, this model will give tangible validation to the public of the benefits that proposition 71 is bringing to California.
There is a world-wide demand for a product that models the human eye for safety testing of chemicals and consumer products. Damage to the cornea is estimated to affect over 10 million people worldwide and household products are involved in 125,000 eye injuries each year. In June of 2007 The European Union started its “REACH” regulation (Registration, Evaluation and Authorization of Chemicals) requiring approximately 3.9 million test animals be used to assess the safety of chemicals (18% for eye irritation) at a cost of over 1.5 billion EURO (data published by the European Commission, Institute for Health and Consumer Protection, Nov., 2004.) Current models use living animals (the “Draize” rabbit test) and are regarded by scientists as being flawed and by the public as cruel. Even with these flaws, alternative tests are not effective substitutes for the Draize. In the beginning of 2008, top officials from the U.S. National Institutes of Health (NIH) and Environmental Protection Agency (EPA) announced a five-year deal promising to share technology, information and other resources that will improve the toxicity testing of chemical compounds using current technologies rather than lab animals. This effort is designed to expand the use of human cells for testing and represents the "birth of a new approach to a crucial problem in public health."
According to the Eye Bank Association of America’s 2006 Eye Banking Statistical Report, there are more than 34,000 corneal transplants performed annually in the US. An additional 150,000 transplants are performed in the rest of the world. Laboratory models of living human cornea will provide a valuable tool for California researchers to study corneal damage and will bypass the current and projected shortages of acceptable human adult corneal tissue for research due to the increased use of laser vision corrective surgery, the increased longevity of the general population, and the increase in incidence of transmissible diseases.
Intellectual property is likely to be generated through this work, resulting in increased valuation for California research organizations involved. This will generate further growth and investment and result in increased employment for Californians and added tax re