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RecruitingNCT07874503Updated Oct 15, 2026

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

A Phase 1 interventional study of HCEC graft in Corneal Endothelial Cell Dysfunction and Corneal Endothelial Cell, sponsored by OcuCell. Recruiting at 1 site in El Salvador. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by OcuCell · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2026; still recruiting 1 month later.
Updated Oct 15, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
21 Years and older
Sex
All
01

Study 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).
02

Conditions studied

  • Corneal Endothelial Cell Dysfunction
  • Corneal Endothelial Cell

Keywords

  • corneal endothelial cell
  • corneal endothelium
  • ophthalmology
  • graft
03

In context

Lead sponsor

This is the only study on the registry with OcuCell as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥21 years
  • Participant or health care agent must understand and sign the 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Treatment

    Endo-Tek

    Combination Product: HCEC graft

Interventions

  • Combination productHCEC graft

    HCEC graft

06

What researchers measure

Primary outcomes

  1. Incidence of treatment-emergent adverse events (TEAE)

    Time frame: 24 weeks post Endo-Tek™ transplantation (post OP)

  2. Incidence of serious adverse events (SAEs)

    Time frame: 24 weeks post Endo-Tek™ transplantation (post-OP)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2026 (actual). Primary completion is estimated for Jun 2027, 8 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 8, 2026
First posted
Oct 15, 2026
StartActual
Oct 7, 2026
Primary completionEst.
Jun 17, 2027
CompletionEst.
Jul 5, 2027
Last update
Oct 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07874503
Lead sponsor
OcuCell
Collaborators
Clinica Quesada
Responsible party
Sponsor
First posted
Oct 15, 2026
Start date
Oct 7, 2026
Primary completion
Jun 17, 2027 (estimated)
Completion
Jul 5, 2027 (estimated)
Last update
Oct 15, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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