RecruitingPhase 1NCT07711561
Simple Non-cultured Endothelial Cell Therapy for Corneal Endothelial Dysfunction
Safety and Efficacy of Simple Non-cultured Endothelial Cell Injection(SNEC-I) Therapy for Corneal Endothelial Dysfunction
Sponsor
Singapore Eye Research Institute
Enrollment
20 participants
Start Date
Jun 22, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
Assessment of safety and efficacy of cell injection therapy generated using non-cultured human corneal endothelial cells in treating corneal endothelial dysfunction
Eligibility
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria1
- 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.
Exclusion Criteria10
- 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
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Interventions
BIOLOGICALCell injection
Direct endothelial cell injection of non-cultured corneal endothelial cells
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07711561