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New Company Applies Regenerative Medicine to Corneal Transplantation

The new approach, not yet tested in patients, involves isolating cells from banked donor corneas to grow replacement corneal tissue in the lab. The advantage is that cells from a single donor could potentially benefit multiple patients with impaired vision.

“This project is an extension of our team’s research to use cells and biomaterials to build replacement tissues and organs in the lab,” said Anthony Atala, M.D., director of the Wake Forest Institute for Regenerative Medicine. “The cornea research, led by Shay Soker [professor of regenerative medicine at Wake Forest], illustrates that the techniques used to build human bladders and urine tubes for successful implantation in patients have the potential to be applied to many different parts of the body.”

The goal of the startup company, known as HCEC, LLC (Human Cultured Endothelial Cells), is to advance the technology to the next level. This includes conducting additional studies needed to apply to the FDA to begin studies in human patients, a process that is expected to take several years.

The cornea, which helps the eye with focus, has cells on its inner surface that are known as corneal endothelial cells (CECs). Their main purpose is to regulate hydration, which helps the cornea maintain clarity. If the CECs become diseased or damaged, vision is blurred.

Because CECs cannot repair themselves, the standard treatment is to replace the cornea or cells with a thin layer of tissue from a cadaveric donor. With the advent of this procedure, there has been increased demand for donor tissue with healthy CECs. The new partnership intends to use regenerative medicine technology to meet this increased demand.

“We believe this innovative initiative has the potential to change the face of corneal transplantation,” Jerry Barker, OSI’s CEO, said. “The formation of HCEC will enable the team to expedite research and development efforts and move toward commercialization at a much faster pace.”

OSI is the sponsor and initial funder of the project, while the Institute for Regenerative Medicine is conducting the research. The North Carolina Eye Bank is providing the ocular tissue and the N.C. Biotechnology Center is assisting with funding through a Collaborative Funding Grant.

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