Simple Non-cultured Endothelial Cell Therapy for Corneal Endothelial Dysfunction
Official title: Safety and Efficacy of Simple Non-cultured Endothelial Cell Injection(SNEC-I) Therapy for Corneal Endothelial Dysfunction
Run by Singapore Eye Research Institute · NCT07711561 · Data updated 2026-11-12
A one-time cell-injection treatment using non-cultured human corneal endothelial cells is being tested to help adults with corneal endothelial problems like bullous keratopathy see if it is safe and helps vision.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Singapore Eye Research Institute Academic / other |
| Locations | 1 site (Hyderabad, Telangana) |
| Status | Recruiting |
| Started | June 22, 2026 |
| Main results expected | July 2028 |
| Study ends | July 2029 |
| Registry record updated | July 17, 2026 |
| Trial ID | NCT07711561 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 21 to 80 with mild to moderate corneal endothelial decompensation or bullous keratopathy and minimal corneal stromal scarring.
✕Probably not a fit
Patients with severe corneal scarring, complex anterior segment issues, or other forms of endothelial disease are less likely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1 interventional trial tests cell injection therapy made from non-cultured human corneal endothelial cells in adults with mild to moderate corneal endothelial decompensation. Researchers will monitor safety and preliminary efficacy by measures such as visual acuity, eye pressure, corneal shape, endothelial cell density, and imaging outcomes, along with tracking postoperative complications. Eligibility targets patients with pseudophakic or aphakic bullous keratopathy or similar endothelial dysfunction with minimal corneal scarring. The study is conducted at the Singapore Eye Research Institute in collaboration with L.V. Prasad Eye Institute in Hyderabad, India. Results from this early study will inform feasibility and design of future trials.
Why it matters
Potential benefit: If successful, patients may experience better vision and safer, less invasive treatment options for corneal endothelial dysfunction.
How similar studies have gone: Early cell-based approaches for corneal endothelium have shown potential in small studies, but this non-cultured cell method is novel and its efficacy remains to be established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Criteria: 1. Severe forms or late-stage presentation of corneal decompensation with severe corneal stromal scarring and or scarring to the DM, unsuitable for SNEC-I. 2. Patients with complex anterior segment complications precluding a successful SNEC-I procedure 3. Patients who have other forms of endothelial dystrophy, traumatic corneal decompensation, or post-inflammatory corneal decompensation 4. Post-laser iridotomy or glaucoma related corneal decompensation 5. Patients not keen to participate in the clinical trial 6. Patients who are below 21 years of age or above 80 years of age 7. Patients who are pregnant 8. Patients who are cognitively impaired 9. Patients who are prisoners 10. Patients with antibiotics/antimycotics allergies
Where it's running
-
L V Prasad Eye Institute
Hyderabad, Telangana, India Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.