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

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

Study Overview

• Status: Recruiting
• Conditions: Corneal Endothelial Dystrophy; Bullous Keratopathy
• Intervention / Treatment: Biological: Cell injection

Detailed Description

The specific aim of this clinical trial is to assess the clinical efficacy and safety outcomes of patients receiving cell injection therapy generated from non-cultured human corneal endothelial cells. Clinical assessments include postoperative visual acuity, intraocular pressure, keratometric astigmatism, spherical equivalent, endothelial cell density, anterior segment optical coherence tomography (ASOCT), contrast sensitivity, as well as any postoperative complications such as graft dislocation or primary graft failure.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 500034
      • Recruiting
      • L V Prasad Eye Institute
      • Contact: Sunita Chaurasia; Phone Number: 9396475020; Email: sunita@lvpei.org
      • Principal Investigator: Sunita Chaurasia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cell Injection; Direct endothelial cell injection	Biological: Cell injection; Direct endothelial cell injection of non-cultured corneal endothelial cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Autokeratorefractometer	Keratometric astigmatism and spherical equivalent: will be measured by an autokeratorefractometer (RK-8100; Topcon, Tokyo, Japan)	1, 3, 6, and 12 months post-operatively
Intraocular pressure	Intraocular pressure: will be measured by a noncontact tonometry (CT-60; Topcon)	1, 3, 6 and 12 months post-operatively
Endothelial Cell Density	Endothelial cell density (ECD): will be measured by a noncontact specular microscope (Konan Medical Corp, Hyogo, Japan). The ECD data will be expressed as percentage of cell loss compared with the donor ECD	1, 3, 6 and 12 months post-operatively
Graft thickness	Graft thickness: will be measured by ASOCT (Visante OCT, Carl Zeiss Meditec)	1, 3, 6 and 12 months post-operatively
Contrast Sensitivity		6, 12 months post-operatively

Collaborators and Investigators

• Sponsor: Singapore Eye Research Institute
• Collaborators: L.V. Prasad Eye Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Cell therapy; Corneal endothelial dystophy; corneal endothelial dysfunction; cell injection
• Additional Relevant MeSH Terms: Corneal Dystrophy, Posterior Polymorphous, 1; Hydrolases; Enzymes; Enzymes and Coenzymes; Carboxylic Ester Hydrolases; Esterases; Carboxylesterase
• Other Study ID Numbers: 2024/2127; CTRI/2026/06/111973 (Registry Identifier: Clinical Trials Registry - India)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No