NCT07874503

RecruitingPhase 1

Safety and Efficacy of Cultivated Allogeneic Corneal Endothe...

OcuCell Source

OcuCell

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

OCU-10124

Study Type

interventional

Estimated enrollment

30

Locations

1 country

Sites

1

Timeline

Study Start

October 7, 2026

Actual (reported)

Primary Completion

June 17, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

July 5, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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).

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: recruiting
Estimated enrollment: 30 participants
Study completion date: July 5, 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
October 7, 2026
Actual (reported)
First Submitted
October 8, 2026
Actual (reported)
First Posted
October 15, 2026
Actual (reported)
Primary Completion
June 17, 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 5, 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: October 15, 2026
Status Verified: October 2026
Last Update Submitted: October 8, 2026

Conditions

Corneal Endothelial Cell Corneal Endothelial Cell Dysfunction

Keywords

corneal endothelial cellcorneal endotheliumophthalmologygraft

Outcome Measures

Primary Outcomes (2)

Incidence of treatment-emergent adverse events (TEAE)
24 weeks post Endo-Tek™ transplantation (post OP)
Incidence of serious adverse events (SAEs)
24 weeks post Endo-Tek™ transplantation (post-OP)

Study Arms (1)

Treatment

EXPERIMENTAL

Endo-Tek

Combination Product: HCEC graft

Interventions

HCEC graftCombination product

HCEC graft

Treatment

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age21 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age ≥21 years
Participant or health care agent must understand and sign the informed consent form (ICF)

Sponsors & Collaborators

Clinica Quesada
Type not reportedcollaborator
OcuCell
Industrylead

Study Sites (1)

Clinica Quesada

San Salvador, El Salvador

RECRUITING

Noe Ramos, MDCONTACT503-2257-9003 coordinador.estudiosclique@gmail.com

Rodrigo Quesada, MDPRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 8, 2026

First Posted

October 15, 2026

Study Start

October 7, 2026

Actual (reported)

Primary Completion

June 17, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Study Completion

July 5, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

October 15, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT07874503
Data provider: ClinicalTrials.gov
Source updated: 2026-10-15
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:34:26 UTC

Locations

SV(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations