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Safety and Efficacy of Cultivated Allogeneic Corneal Endothelial Cells Attached to a Hydrogel Substrate (Endo-Tek™) as a Treatment for Corneal Endothelial Cell Dysfunction

RecruitingPhase 1Ages 21 Years - anyAllOcuCell
NCT07874503 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Primary Objective: • To determine the safety and feasibility of using Endo Tek™ for the treatment of corneal endothelial disease/dysfunction. Secondary Objective: • To investigate the preliminary efficacy of Endo-Tek™ in the treatment of corneal endothelial disease by comparing visual acuity (VA), corneal thickness, and corneal endothelial cell (CEC) density in participants pre-operation (pre-OP) and post-operation (post-OP).

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥21 years * Participant or health care agent must understand and sign the informed consent form (ICF) * Participant must be medically suitable, willing to undergo the surgery and study procedures, and able to attend all follow-up visits * Phakic or pseudophakia with Fuchs dystrophy or pseudophakic bullous keratopathy Exclusion Criteria: * Corneal stromal scarring making standard EK surgery unsuitable at Screening Visit * Abnormal cornea or anterior segment of eye other than uncomplicated pseudophakia and corneal edema at Screening Visit
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What it tests

  • HCEC graft
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Where

1 site
Clinica Quesada
San Salvador, El Salvador
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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