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ISCO to provide corneal epithelial cells for FDA clinical trials
Oceanside, California | Friday, January 18, 2008, 08:00 Hrs  [IST]

Aimed at creating a tissue transplant technology to improve photorefractive keratectomy (PRK), International Stem Cell Corporation (ISCO) unveiled its plans to provide corneal epithelial cells for use in Federal Drug Administration (FDA) clinical trials.

The corneal epithelial cells were derived from the company's Parthenogenetic stem cells and human keratinocytes (a type of skin cell).

ISCO entered into a research agreement with Dr. Paul H. Chen, M.D. who has developed the cell transfer technology. He has a separate collaboration with the University of Michigan and is expanding his research team to include the University of California San Diego Shiley Eye Centre and Burnham Research Institute, both located in La Jolla, California, and State University New York (SUNY) Albany. Dr Chen is currently at Scripps Memorial, La Jolla and Scripps Encinitas Hospitals.

The new step is part of ISCO's efforts to increase the clinical utility of its discoveries in culturing corneal-like tissues from its Parthenogenetic stem cells and to provide human stem cells for the study and cure of disease. Parthenogenetic cells come from unfertilised human eggs and can be immune-matched to millions of people therefore reducing ethical and immune rejection issues.

"Our goal, in addition to conducting our own clinical trials in our targeted areas of ocular, liver and pancreatic diseases, is to do collaborations with other prominent researchers and provide our Parthenogenetic stem cells for their human trials," said Jeff Krstich, CEO, International Stem Cell Corporation. "It is exciting to have our cells involved in studies that could lead to a safer and more effective treatment that hopefully will provide improved visual recovery, less pain, and an improved refractive correction outcome".

"If successful, such technology might also provide broader applications for the treatment of a variety of conditions, including non-healing epithelial defects, such as diabetic epithelial defects, neuropathic epithelial defects, and alkali burn epithelial defects," added Krstich.

PRK was the first clinical laser procedure to be developed for refractive vision correction, but lost favour to LASIK because the PRK procedure calls for laser ablation of the surface of the cornea which is relatively more painful and requires a longer healing time. PRK's advantages, however, include better vision improvement and fewer side effects associated with complications of the surgical "flap" that is created in the LASIK process. The PRK procedure does not require the creation of a flap and is associated with less risk of corneal ectasia, dry eyes, flap striae and epithelial in growth.

International Stem Cell Corporation is a California-based biotechnology company focused on developing therapeutic and research products. ISCO's technology, Parthenogenesis, results in the creation of pluripotent human stem cell lines from unfertilised human eggs that can be transplanted without immune-rejection.

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