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How is Cell Replacement Shaping the Future of Corneal Edema Treatment?

How is Cell Replacement Shaping the Future of Corneal Edema Treatment?

November 27, 2023

Corneal edema or swelling stands as one of the most prevalent reasons for individuals requiring a corneal transplant. This condition arises when the endothelial cells, which line the innermost layer of the cornea, diminish in number, leading to corneal swelling and a subsequent loss of clarity. Traditionally, the only way to restore vision has been through corneal transplantation surgery. However, researchers are currently exploring an innovative approach to address this issue by replacing the deficient cells through a simple injection of donor cells.

In this method, donor cells are loaded with superparamagnetic nanoparticles and subsequently injected into the front of the eye. Following the injection, a magnetic eye patch is positioned in front of the eye, and the patient assumes a face-down position. The magnet facilitates the precise positioning of the cells, where they adhere and integrate. The initial cohort of 21 patients treated using this technique reported an enhancement in their vision.

“To our knowledge, we are the first group to show that injection of endothelial cells without surgical intervention can improve vision in subjects with Fuchs endothelial corneal dystrophy,” said Ellen Koo, MD, lead researcher and associate professor at the Bascom Palmer Eye Institute, University of Miami.  “We are excited for the future.”

All 21 subjects enrolled in the study presented corneal edema attributed to Fuchs endothelial corneal dystrophy. Some participants underwent endothelium removal (descemetorhexis) before the intracameral injection of cells, while others did not. The treatment was administered at six different centers across the United States, testing four doses (50,000, 150,000, 500,000, one million cells).

The primary focus of the study was on safety. After a six-month follow-up period, no adverse events related to the product were observed. Intraocular pressure remained stable, and there were no signs of inflammation. Notably, a dose-dependent improvement in vision persisted up to six months post-injection, and none of the patients required subsequent surgery.

While corneal transplantation surgery proves to be an effective treatment, its implementation necessitates a highly skilled corneal surgeon and access to donor tissue, both of which are readily available in the United States. However, many countries face shortages of both resources. Dr. Koo envisions that adopting a cell replacement approach could potentially broaden access to sight-saving treatments for individuals worldwide.

“With this treatment of cell therapy, hundreds of patients can be treated with one donor cornea,” Dr. Koo said. “Greater accessibility, as well as the fact that the patient does not need to go to an operating room for treatment, would mean more patients at earlier stages of disease can receive treatment for corneal edema.”

Importantly, undergoing this form of treatment does not rule out the possibility of patients undergoing future corneal transplant surgery if necessary. This flexibility potentially enables the treatment of patients at an earlier stage of the disease. Moreover, the administration of this treatment is not restricted to corneal specialists; any ophthalmologist could offer it. This inclusivity expands access to a broader patient population.

“There is a new frontier in the treatment of corneal endothelial dysfunction and this technology will certainly shift the therapeutic paradigm,” Dr. Koo said.