Wake Forest Baptist Medical Center, North Carolina Eye Bank, and the company Ocular Systems Inc., all in Winston-Salem, are forming a new company to create bioengineered tissue for cornea transplants. The startup company, HCEC LLC (for human cultured endothelial cells), is expected first to advance the technology to the point of an FDA submission for approval.
The cornea is the outer lens in the front of the eye that helps focus the eyes. The cells that line the inside of the cornea, known as corneal endothelial cells, pump fluid out of the cornea. Corneal endothelial cells, if damaged, cannot repair themselves, thus must be replaced.
Transplants of the cornea are a relatively common procedure and often conducted with a local anesthetic. Corneas for transplant are currently provided by recently deceased donors who will their corneas to an eye bank that tests the cornea for safety and makes them available to transplant surgeons. A newer procedure, called lamellar keratoplasty, replaces only the corneal endothelial cells rather than the entire cornea, but still requires tissue from a deceased donor.
The goal of the new joint venture is to use regenerative medicine to create new corneal tissue, rather than depend on corneas from deceased donors. The technique for this new approach will isolate cells from banked corneal tissue, and grow replacement tissue in the lab. If successful, this procedure would make it possible to grow replacement tissue for multiple patients from a single donor.
Ocular Systems that provides donor tissue for for corneal transplants, offered the initial funding for the joint venture. Additional funding came from the North Carolina Biotechnology Center.
The Institute for Regenerative Medicine, part of Wake Forest Baptist, is conducting the initial research, led by Shay Soker, professor of regenerative medicine. The work needed to reach the point of seeking FDA approval to begin trials with human patients is still several years away. However, says Ocular Systems CEO Jerry Baker, “The formation of HCEC LLC will enable the team to expedite research and development efforts and move toward commercialization at a much faster pace.”
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