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NCT05909735 · ClinicalTrials.gov registry record · Phase 1
Treatment of LSCD With DM
A Phase 1 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT05909735: Completed Phase 1 study, sponsored by University of Minnesota.
NCT05909735 is a Phase 1 study that has completed, run by University of Minnesota. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05909735, a Phase 1 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
Limbal Stem Cell Deficiency (LSCD) is a blinding disease that accounts for an estimated 15-20% of corneal blindness worldwide. Current treatments are limited. Traditional corneal transplantation with penetrating keratoplasty (PKP) is ineffective in treating these patients. Without a healthy population of limbal stem cells (LSC) to regenerate the corneal epithelium, standard corneal transplants will not re-epithelialize and will rapidly scar over or melt. The limbal niche is the microenvironment surrounding the LSCs that is critical for maintaining their survival and proliferative potential under physiologic conditions. Extracellular signals from the microenvironment are critical to the normal function and maintenance of pluripotent stem cells. Identifying an effective niche replacement is thus an important focus of limbal stem cell research and critical for advancing treatments for LSCD. Descemet's membrane (DM), an acellular, naturally occurring, basement membrane found on the posterior surface of the cornea, is a promising niche replacement. DM is routinely isolated and transplanted intraocularly with associated donor corneal endothelium for treatment of diseases like Fuchs' dystrophy and corneal bullous keratopathy that specifically affect DM and corneal endothelium. However, its application on the ocular surface has not been explored. DM is optically clear and highly resistant to collagenase digestion. This makes it very attractive as a long-term corneal on-lay and niche replacement on the surface of the eye. The anterior fetal banded layer of DM shares key compositional similarities with limbal basement membrane, which is a major component of the limbal niche. These similarities include limbus-specific extracellular matrix proteins such as collagen IV that is restricted to the α1, α2 subtypes, vitronectin, and BM40/SPARC. Of these, vitronectin and BM40/SPARC are known to promote proliferation of LSCs and induced pluripotent stem cells (iPSC) in culture. Beca
Primary Outcome
Visual Acuity: Improvement in visual acuity over time will be measured as the difference in post-op visual acuity at post-operative week 1, month 1, month 3, and month 6 compared to pre-op visual acuity. Visual acuity will be assessed in study eyes with a standard Snellen Eye Chart.
Interventions
- PROCEDURE transplantation of a Descemet's Membrane corneal onlay, partial LSCD
- PROCEDURE transplantation of a Descemet's Membrane corneal onlay, total/near-total LSCD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2023-11-30 |
| Est. Completion | 2025-12-01 |
| Phase | Phase 1 |
What the finished NCT05909735 record still lists
NCT05909735 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which transplantation of a Descemet's Membrane corneal onlay, partial LSCD is the first listed.
NCT05909735 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05909735 about?
NCT05909735 is a clinical study titled "Treatment of LSCD With DM". Limbal Stem Cell Deficiency (LSCD) is a blinding disease that accounts for an estimated 15-20% of corneal blindness worldwide. Current treatments are limited. Traditional corneal transplantation with penetrating keratoplasty (PKP) is ineffective in treating these patients. Without a healthy populati...
What is the current status of trial NCT05909735?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2023-11-30. Estimated completion is 2025-12-01.
What interventions are being tested in trial NCT05909735?
The interventions under investigation include: transplantation of a Descemet's Membrane corneal onlay, partial LSCD (PROCEDURE), transplantation of a Descemet's Membrane corneal onlay, total/near-total LSCD (PROCEDURE).
Who is sponsoring clinical trial NCT05909735?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05909735's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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