NCT07874503 Safety and Efficacy of Cultivated Allogeneic Corneal Endothelial Cells Attached to a Hydrogel Substrate (Endo-Tek™) as a Treatment for Corneal Endothelial Cell Dysfunction
| NCT ID | NCT07874503 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | OcuCell |
| Condition | Corneal Endothelial Cell Dysfunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-10-07 |
| Primary Completion | 2027-06-17 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2026-10-07 with a primary completion date of 2027-06-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT07874503 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Corneal Endothelial Cell Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07874503 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07874503 currently recruiting?
Yes, NCT07874503 is actively recruiting participants. Visit ClinicalTrials.gov or contact OcuCell to inquire about joining.
Where is the NCT07874503 trial being conducted?
This trial is being conducted at San Salvador, El Salvador.
Who is sponsoring the NCT07874503 clinical trial?
NCT07874503 is sponsored by OcuCell. The trial plans to enroll 30 participants.