NCT07711561

Brief Summary

Assessment of safety and efficacy of cell injection therapy generated using non-cultured human corneal endothelial cells in treating corneal endothelial dysfunction

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
36mo left

Started Jun 2026

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Jun 2026Jul 2029

Study Start

First participant enrolled

June 22, 2026

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

July 13, 2026

Last Update Submit

July 13, 2026

Conditions

Bullous KeratopathyCorneal Endothelial Dystrophy

Keywords

Cell therapyCorneal endothelial dystophycorneal endothelial dysfunctioncell injection

Outcome Measures

Primary Outcomes (1)

  • BSCVA

    Snellen best spectacle-corrected visual acuity (BSCVA). The Snellen BSCVA will be converted to logarithm of the minimum angle of resolution visual acuity for statistical analysis.

    1, 3, 6, 12 months post-operatively

Secondary Outcomes (5)

  • Autokeratorefractometer

    1, 3, 6, and 12 months post-operatively

  • Intraocular pressure

    1, 3, 6 and 12 months post-operatively

  • Endothelial Cell Density

    1, 3, 6 and 12 months post-operatively

  • Graft thickness

    1, 3, 6 and 12 months post-operatively

  • Contrast Sensitivity

    6, 12 months post-operatively

Study Arms (1)

Cell Injection

EXPERIMENTAL

Direct endothelial cell injection

Biological: Cell injection

Interventions

Cell injectionBIOLOGICAL

Direct endothelial cell injection of non-cultured corneal endothelial cells

Cell Injection

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have mild to moderate corneal endothelial decompensation or bullous keratopathy, but with minimal corneal stromal scarring resulting from irreversible post-surgical corneal decompensation, specifically, all forms of pseudophakic or aphakic bullous keratopathy.

You may not qualify if:

  • Severe forms or late-stage presentation of corneal decompensation with severe corneal stromal scarring and or scarring to the DM, unsuitable for SNEC-I.
  • Patients with complex anterior segment complications precluding a successful SNEC-I procedure
  • Patients who have other forms of endothelial dystrophy, traumatic corneal decompensation, or post-inflammatory corneal decompensation
  • Post-laser iridotomy or glaucoma related corneal decompensation
  • Patients not keen to participate in the clinical trial
  • Patients who are below 21 years of age or above 80 years of age
  • Patients who are pregnant
  • Patients who are cognitively impaired
  • Patients who are prisoners
  • Patients with antibiotics/antimycotics allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

L V Prasad Eye Institute

Hyderabad, Telangana, 500034, India

RECRUITING

MeSH Terms

Conditions

Corneal Dystrophy, Posterior Polymorphous, 1

Interventions

Carboxylesterase

Intervention Hierarchy (Ancestors)

Carboxylic Ester HydrolasesEsterasesHydrolasesEnzymesEnzymes and Coenzymes

Study Design

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

Study Record Dates

First Submitted

July 13, 2026

First Posted

July 17, 2026

Study Start

June 22, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2029

Last Updated

July 17, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)