Collaboration a Key in Effort to Develop Engineered Replacement Corneas

The story behind HCEC, LLC, one of the newest companies at Innovation Quarter, is nine years in the making.

HCEC is a partnership between Ocular Systems, Inc., a company that has been at Albert Hall since its founding in 2004, Wake Forest Baptist Medical Center and the North Carolina Eye Bank. HCEC is working to develop a new technology aimed at engineering corneal tissue implants in the lab for transplantation into patients facing corneal blindness.

“We believe this innovative initiative has the potential to change the face of corneal transplantation,” says Jerry Barker, the president of Ocular Systems and managing partner of HCEC.

About 25 people are currently working on HCEC’s effort to develop the engineered replacement corneas, which involves scientists with the Wake Forest Institute for Regenerative Medicine. Shay Soker, PhD, a professor of regenerative medicine, is lead scientist for the WFIRM team. Belinda Wagner was hired by Ocular Systems as product translation director to provide oversight, expertise and guidance to the project.

The goal is to isolate cells from ‘banked’ donor corneas to grow replacement corneal tissue in the lab. If the effort is successful, cells from a single donor could potentially benefit multiple patients with impaired vision.

The cornea is the transparent dome at the front of the eye that helps with focus. The cells that line the inside of the cornea, known as corneal endothelial cells, pump fluid out of the cornea. When those cells become diseased or damaged, less fluid is pumped out and vision becomes blurred. Endothelial cells cannot repair themselves, which is why the standard treatment is a cornea transplant from a cadaveric donor.

Every year in the U.S., about 40,000 cornea transplants are conducted; 50 percent of those are because of endothelial issues. There are thousands more transplants needed overseas, where there are fewer donors. Barker says the need for endothelial cells is clear.

The project is a natural outgrowth of the work done at Ocular Systems, which processes cadaveric corneal tissue for endothelial replacement surgeries. It provides the most replacement tissues in the country for such surgeries.

Ocular Systems also developed a surgical delivery device for endothelial cells, the Endoserter(TM). As another example of park collaboration, Barker noted that Cathtek Inc., a medical device manufacturer and prior tenant in Albert Hall, was instrumental in the development of the Endoserter device. Cathtek has since moved into its own building on Reidsville Road.

It will likely be several years before the research determines if the cultured endothelial cells are viable for transplantation. The HCEC team, Barker says, has two key hurdles: proving to the FDA that the cells grown in the lab are, in fact, true endothelial cells, and devising a matrix that can deliver functioning cells for transplantation.

Barker and Wagner are pleased with progress to date and believe in the collaboration that has helped get HCEC off the ground.

“Part of my motivation for being here is love of my community,” Wagner says. “I think this project offers the opportunity to build a product development and innovation strategy for other projects to follow.”

Barker says collaboration between industry, government and academia is crucial to the success of fledgling companies such as HCEC, which is being aided in part by a grant from the N.C. Biotechnology Center.