Magnetic cell therapy is a potential treatment option for corneal endothelial dysfunction

Publication
Article
Digital EditionOphthalmology Times: June 2024
Volume 49
Issue 6

Phase 1 multicenter study demonstrates early signs of efficacy.

(image Credit: AdobeStock/BillionPhotos.com)

(image Credit: AdobeStock/BillionPhotos.com)

Reviewed by Sumit Garg, MD, ABO

Magnetic cell delivery of human corneal endothelial cells (HCECs) to the anterior chamber seems to be a safe cell-based treatment that is exhibiting early signs of efficacy for corneal endothelial cell dysfunction, Sumit Garg, MD, ABO, reported at the American Society of Cataract and Refractive Surgery 2024 annual meeting in Boston, Massachusetts.

Garg is with the UCI Gavin Herbert Eye Institute, UCI Health, in Irvine, California. The success of this type of treatment, Garg said, will represent a paradigm shift for treating corneal cell dysfunction.

Study design

Garg reported on a phase 1 multicenter study (NCT04894110) to determine the safety and tolerability of a single injection of magnetic HCECs (EO2002; Emmecell) in patients who had symptomatic corneal edema secondary to Fuchs corneal dystrophy or pseudophakic bullous keratopathy. All patients have a best-corrected visual acuity (BCVA) of 20/40 or worse. The study was designed to have 2 parts and to enroll up to 42 patients in the 2 groups.

The first part included 21 patients (group 1) with whom 4 treatment doses were tested (ie, injection of 50,000, 150,000, 500,000, and 1 million cells with or without endothelial brushing or Descemet stripping). The patients were followed for 6 months.

Part 2 included 21 additional participants and is a randomized, double-masked trial that picks up where part 1 left off and tests the 3 highest doses identified in part 1. The primary outcome is safety. Secondary end points are decreased corneal thickness and improved BCVA.

The technologic steps

Garg described the steps in the cell preparation process. First, the HCECs from a donor cornea are expanded in culture. One donor cornea can yield enough cells to enable treatment of hundreds of patients, which addresses the donor supply. The donor HCECs then are combined with magnetic nanoparticles, and the magnetized HCECs are injected into the anterior chamber without the need for endothelial brushing or disruption.

The patient wears a magnetic eye patch for up to 3 hours. This step facilitates localization and integration of magnetic HCECs into the endothelial layer.

Treatment effect

A representative case was that of a patient injected with 500,000 cells during the 5-minute procedure, requiring no endothelial brushing or Descemet stripping. At 26 weeks postoperatively, the patient had a central corneal thickness decrease of 217 µm and an increase in the BCVA of 18 letters, Garg explained.

In another representative example in a case without endothelial brushing or Descemet stripping, the baseline BCVA was 20/50 with a pachymetry value of 651. At 1 year of follow-up, the BCVA was 20/30 with a pachymetry value of 601.

Among the 4 doses originally tested, no associated adverse effects of the treatment were recorded. The IOP was stable in the treated patients. No infections or inflammation developed.

Early signs of efficacy were apparent with the 150,000, 500,000, and 1 million cell doses. Greater efficacy was associated with the 2 higher doses, which were associated with higher increases in the BCVA.

Part 2

Twenty-one patients have been enrolled in a randomized and double-masked fashion. Participants are randomly assigned 1:1:1 and received 1 injection of EO2002 at one of the 3 most effective doses identified in part 1: 150,000, 500,000, or 1 million HCECs. The goal of this part of the study is to continue to ensure safety and to pinpoint the most effective dose.

“Magnetic corneal cell therapy is a novel technology that is well tolerated,” Garg said. “Cells obtained from 1 donor cornea can treat hundreds of patients in a simple procedure that can be performed in the clinical setting without surgery. Further studies are warranted to continue the development of this product for corneal endothelial dysfunction.”

Another clinical investigation

The effect of EO2002 is also being evaluated in association with cataract surgery. Two groups of patients are included in this clinical trial. Group 1 includes 6 patients who received an injection of the cells during cataract surgery; group 2 includes 6 patients who received an injection
1 week after cataract surgery.

The study end points are safety, increased or stable endothelial cell density, no decrease in the BCVA that is expected to improve due to the cataract surgery, and a stable central corneal thickness in patients with at-risk corneal endothelium.

Sumit Garg, MD, ABO
E: gargs@hs.uci.edu
Garg is a consultant/adviser to Emmecell. He presented “Treatment of Corneal Endothelial Dysfunction With Magnetic Cell Therapy” at the American Society of Cataract and Refractive Surgery 2024 annual meeting in Boston, Massachusetts.
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