International Stem Cell Corporation (OTCBB: ISCO),
www.intlstemcell.com,
announced today that multiple international meetings taking place
between ISCO’s executive management and researchers and clinicians from
commercial entities in both Asia and Europe revealed significant
clinical-commercial opportunities for the company’s stem cell-derived
human cornea technology in those regions.
ISCO 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. The 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.
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 refined greatly and is now
typically performed as a one-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.
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.
In the US 52,487 transplantations were performed in 2008. However, 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.”
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
hard end points of vision restoration, large available patient pools and
modest competition from alternative technologies, particularly such
involving live corneas.”
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