Corneal Endothelial Cell DysfunctionPhase 1NCT07874503
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 study testing HCEC graft in people with Corneal Endothelial Cell Dysfunction and Corneal Endothelial Cell, run by OcuCell at 1 site in El Salvador.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Corneal Endothelial Cell Dysfunction, Corneal Endothelial Cell
- What is being tested?
- HCEC graft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEl Salvador
- Study dates
- 7 Oct 2026to 5 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
El Salvador1 site, 1 recruiting
- Recruiting
Clinica Quesada
San Salvador
Noe Ramos, MD, 503-2257-9003, coordinador.estudiosclique@gmail.com
Rodrigo Quesada, MD
About this study
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).
- Being tested
- HCEC graft
- Keywords
- corneal endothelial cell, corneal endothelium, ophthalmology, graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCEC graftCombination product
HCEC graft
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Endo-Tek Receives: Combination Product: HCEC graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAE)
Measured: 24 weeks post Endo-Tek™ transplantation (post OP)
Incidence of serious adverse events (SAEs)
Measured: 24 weeks post Endo-Tek™ transplantation (post-OP)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start7 Oct 2026
- Primary completion17 Jun 2027 (estimated)
- Study completion5 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal Endothelial Cell DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OcuCell
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinica Quesada
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874503
- Sponsor's protocol ID
- OCU-10124
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Cultivated Allogeneic Corneal Endothelial Cells Attached to a Hydrogel Substrate (Endo-Tek™) as a Treatment for Corneal Endothelial Cell Dysfunction
- ClinicalTrials.gov ID
- NCT07874503
- Acronym / sponsor ID
- OCU-10124
- Keywords
- corneal endothelial cell, corneal endothelium, ophthalmology, graft
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- OcuCellIndustry (pharma, biotech, devices)
- Collaborators
- Clinica Quesada
- Study start
- 7 Oct 2026 (actual)
- Primary completion
- 17 Jun 2027 (estimated)
- Study completion
- 5 Jul 2027 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Combination Product: HCEC graftEndo-Tek |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HCEC graftHCEC graft | Combination product | Treatment |
Primary outcome
Incidence of treatment-emergent adverse events (TEAE)
Time frame: 24 weeks post Endo-Tek™ transplantation (post OP)
Incidence of serious adverse events (SAEs)
Time frame: 24 weeks post Endo-Tek™ transplantation (post-OP)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HCEC graft in people with Corneal Endothelial Cell Dysfunction and Corneal Endothelial Cell, run by OcuCell at 1 site in El Salvador.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in El Salvador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAE) (time frame: 24 weeks post Endo-Tek™ transplantation (post OP)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.