Tissue-engineered endothelial keratoplasty with lab-grown corneal endothelial grafts
Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty (TE-EK)
PHASE1 · Singapore Eye Research Institute · NCT04319848
This trial will test whether a graft made from lab-grown human corneal endothelial cells can safely restore vision in adults with mild to moderate corneal endothelial failure such as Fuchs' dystrophy or bullous keratopathy.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Sponsor | Singapore Eye Research Institute (other) |
| Locations | 1 site (Singapore) |
| Trial ID | NCT04319848 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional trial implants tissue-engineered endothelial keratoplasty (TE-EK) graft material created from cultured human corneal endothelial cells propagated using a regulatory-approved dual media method. Surgeries follow current endothelial keratoplasty (EK) protocols at the Singapore National Eye Centre with standard postoperative care and scheduled follow-up visits. Clinical outcomes include visual acuity, intraocular pressure, keratometric astigmatism, spherical equivalent, endothelial cell density, AS-OCT imaging, contrast sensitivity, and monitoring for complications such as graft dislocation or primary graft failure. The primary focus of this first-in-human study is safety, with preliminary efficacy signals recorded as secondary outcomes.
Who should consider this trial
Good fit: Adults aged 21 to 80 with mild to moderate corneal endothelial decompensation (including Fuchs' dystrophy or pseudophakic/aphakic bullous keratopathy) and minimal stromal scarring, without complex anterior segment issues, are the ideal candidates.
Not a fit: Patients with severe stromal scarring, complex anterior segment problems that preclude EK, other non-endothelial causes of decompensation (traumatic or post-inflammatory), glaucoma- or post-laser iridotomy-related decompensation, those younger than 21 or older than 80, pregnant patients, or those unwilling to participate are unlikely to benefit from TE-EK in this protocol.
Why it matters
Potential benefit: If successful, this approach could restore endothelial function and improve vision while reducing dependence on donor corneas.
How similar studies have performed: Early preclinical work and some clinical cell-injection approaches using cultured corneal endothelial cells have shown promising results, but implantation of tissue-engineered grafts remains relatively novel with limited Phase 1 human data.
Eligibility criteria
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 a variety of conditions including: * Fuchs' endothelial dystrophy * Post-surgical corneal decompensation (irreversible) - all forms of pseudophakic or aphakic bullous keratopathy Exclusion Criteria: * Severe forms or late stage presentation of corneal decompensation with severe corneal stromal scarring, unsuitable for TE-EK surgery as opposed to penetrating keratoplasty * Patients with complex anterior segment complications precluding a successful TE-EK 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 who are allergic to antibiotics
Where this trial is running
Singapore
- Singapore Eye Research Institute — Singapore, Singapore (RECRUITING)
Study contacts
- Principal investigator: Jodhbir Mehta — Singapore Eye Research Institute
- Study coordinator: Lee Yan Lim
- Email: lim.lee.yan@seri.com.sg
- Phone: +65 6576 7322
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mild to Moderate Corneal Endothelial Decompensation, Bullous Keratopathy, Fuchs' Endothelial Dystrophy, Post-surgical Corneal Decompensation