Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by University of Minnesota. The registered enrollment target is 19 participants.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05909735
The ClinicalTrials.gov registry entry for NCT05909735 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.