International Stem Cell Corporation (ISCO.OB), announced that it has discovered and filed for patents on a cell culture process for the synthesis of fully human, cornea-like structures using either its proprietary human parthenogenic stem cell (hpSC) technology or human embryonic stem cells.
ISCO’s parthenogenic stem cell technology enables synthesis of corneal tissue that is immune matched for millions of people. This may significantly reduce the rejection rates of 15-30% experienced in current medical practice.
Brian Lundstrom, ISCO’s President, says, “Given the substantial unmet medical need for human corneas in Asia and Europe, ISCO has commenced a targeted effort to partner with clinical development and commercialization partners in these regions. We believe clinical development in this area is particularly attractive given the rapid and easily measurable outcomes of vision restoration, the availability of large patient pools and modest competition from alternative technologies, particularly such involving live corneas.”
Cornea-related loss or reduction of vision can be caused by physical injuries, infections and a range of degenerative diseases that affect up to 10 million people worldwide. ISCO’s corneal structure may fit into existing medical applications where the surgical techniques are well established. Cornea transplantation has been greatly refined and is now typically performed as a one-to-two hour outpatient procedure using donated corneas from human cadavers. While most operations previously involved the entire corneal structure, it is now common to selectively replace solely the damaged portion.
In the US 52,487 transplantations were performed in 2008. Although the supply of corneas in the US is adequate at this time, a shortage of corneal tissue has been a significant problem in much of the rest of the world. Only 3,000-4,000 procedures were performed annually in the UK and Germany due to limited cornea supply. In Asia, the shortage of corneas has been an even greater problem. For example, in Japan during a ten-year period only 16,000 transplantations were performed. China has had over 2 million patients on waiting lists yet only a few thousand procedures have been performed annually. Over 3 million Indians are reported to be blind due to corneal defects.
Dr. Radhika Tandon, Professor of Ophthalmology and Officer-in-charge at the National Eye Bank, All India Institute of Medical Sciences (AIIMS) in New Delhi says: “Corneal vision impairment is a large medical problem in India and other developing countries. India has access to less than 20,000 suitable corneas per year yet would need 200,000 corneas to take care of the existing backlog and the new cases added each year. Supply of synthetic human corneas would alleviate the problem and provide great socio-economic benefit by enabling millions of Indians to get back to work and live a more normal life.”
While a number of companies are exploring synthetic approaches of combining layers of epithelial cells with layers of stroma-like materials such as collagen, ISCO is the only company known currently that actually produces live human cornea tissue, without the risk of infectious diseases and with an opportunity for immune matching.
The cornea-like structures are grown to clear hollow spheres with a size of 8-10 mm in diameter and contain tissues and cells similar to those found in normal human corneal tissue. Portions or all of these structures may be suitable for cornea transplantation in humans. Permeability and ocular histology testing has demonstrated compatibility with natural corneas. Future steps include scale-up of the manufacturing process and IND-enabling studies, to be conducted domestically and through international collaborations.
Source: http://www.prlog.org/10554486-international-stem-cell-corporation-files-for-cornea-transplantation-patents.html
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