What is the mechanism of action of this treatment?

Corneal edema is commonly treated with corneal transplantation, but innovative approaches like the EO2002 trial are exploring the use of cultured human corneal endothelial cells (HCECs) combined with biocompatible magnetic nanoparticles. This method aims to re-populate the corneal endothelium, which is crucial for maintaining corneal transparency and proper vision. The magnetic nanoparticles help direct and retain the HCECs at the site of injury, promoting effective cell integration and function. This targeted cell therapy could offer a less invasive alternative to transplantation, reducing surgical risks and potentially improving outcomes for patients with advanced corneal edema.

What side effects are associated with this type of intervention?

Common treatments for corneal edema, particularly those involving cultured human corneal endothelial cells (HCECs) with biocompatible magnetic nanoparticles, are still under investigation. However, potential side effects may include inflammation, infection, and rejection of the transplanted cells. More traditional treatments, such as corneal transplantation, can also lead to complications like graft failure, increased intraocular pressure, and cataract formation. Topical treatments like hypertonic saline may cause temporary stinging or burning sensations. Overall, while innovative treatments like EO2002 show promise, they require further study to fully understand their safety profiles.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically involving cultured human corneal endothelial cells with biocompatible magnetic nanoparticles for corneal edema. The primary treatment for advanced corneal edema remains corneal transplantation, including penetrating keratoplasty (PK) and endothelial keratoplasty (EK). These surgical procedures are the standard of care for patients whose condition cannot be managed with topical treatments like hypertonic saline.

What other types of research exist?

Promising novel alternatives to EO2002 for corneal edema patients include: 1) Rho kinase inhibitors (e.g., ripasudil), which promote corneal endothelial cell proliferation and migration; 2) Injection of cultured corneal endothelial cells without magnetic nanoparticles, which aims to restore endothelial function; 3) Descemet membrane endothelial keratoplasty (DMEK), a less invasive surgical option compared to full-thickness corneal transplantation; and 4) Gene therapy approaches targeting corneal endothelial cell dysfunction. These treatments are in various stages of research and clinical trials and may offer effective options for patients in 2024.

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Cell Therapy

EO2002 at different doses for Corneal Edema

Phase 1

Waitlist Available

Research Sponsored by Emmecell

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 26 weeks

Awards & highlights

Summary

This trial tests a new treatment for severe corneal swelling using lab-grown cells and tiny magnetic particles. It aims to help patients who would otherwise need a corneal transplant by repairing their damaged corneas in a minimally invasive way.

Who is the study for?

This trial is for adults over 21 with corneal edema due to endothelial dysfunction, often from Fuchs' dystrophy or after cataract surgery. Participants must have symptoms not managed by topical treatments and qualify for corneal transplant surgery. Exclusions include other eye diseases, recent eye surgeries, certain vision impairments in the non-study eye, pregnancy, current participation in another drug trial, and conditions that may affect study results.

What is being tested?

The study tests EO2002 at different doses as a potential treatment for corneal edema. It's an innovative therapy involving cultured human corneal endothelial cells combined with magnetic nanoparticles injected into the eye to restore function without full surgery. The safety and tolerability of three EO2002 doses will be evaluated alongside two surgical preparation methods.

What are the potential side effects?

As this is a phase 1 trial primarily assessing safety and tolerability, specific side effects are being investigated but may include typical reactions related to ocular injections such as discomfort at the injection site, redness, swelling of the eyes or eyelids, increased tear production or possible visual disturbances.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 26 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~26 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability of EO2002]

Secondary study objectives

Effect of EO2002 (+/-EB or DS) on best corrected visual acuity (BCVA).

Effect of EO2002 (+/-EB or DS) on corneal thickness

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: EO2002 treatment - Group 1Experimental Treatment1 Intervention

Group II: EO2002 treatment - Group 2 - low doseActive Control1 Intervention

Group III: EO2002 treatment - Group 2 - mid doseActive Control1 Intervention

Group IV: EO2002 treatment - Group 2 - high doseActive Control1 Intervention

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Corneal edema is commonly treated with corneal transplantation, but innovative approaches like the EO2002 trial are exploring the use of cultured human corneal endothelial cells (HCECs) combined with biocompatible magnetic nanoparticles. This method aims to re-populate the corneal endothelium, which is crucial for maintaining corneal transparency and proper vision. The magnetic nanoparticles help direct and retain the HCECs at the site of injury, promoting effective cell integration and function. This targeted cell therapy could offer a less invasive alternative to transplantation, reducing surgical risks and potentially improving outcomes for patients with advanced corneal edema.

Microtubule Stabilization Protects Hypothermia-Induced Damage to the Cytoskeleton and Barrier Integrity of the Corneal Endothelial Cells.Targeted transplantation of human umbilical cord blood endothelial progenitor cells with immunomagnetic nanoparticles to repair corneal endothelium defect.Nanotechnology in corneal neovascularization therapy--a review.

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Who is running the clinical trial?

EmmecellLead Sponsor

3 Previous Clinical Trials

79 Total Patients Enrolled

2 Trials studying Corneal Edema

47 Patients Enrolled for Corneal Edema

Noelia KunzevitzkyStudy DirectorEmmecell

Media Library

EO2002 (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04894110 — Phase 1

Corneal Edema Research Study Groups: EO2002 treatment - Group 1, EO2002 treatment - Group 2 - low dose, EO2002 treatment - Group 2 - mid dose, EO2002 treatment - Group 2 - high dose

Corneal Edema Clinical Trial 2023: EO2002 Highlights & Side Effects. Trial Name: NCT04894110 — Phase 1

EO2002 (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04894110 — Phase 1

Corneal Edema Patient Testimony for trial: Trial Name: NCT04894110 — Phase 1

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