DM Corneal Onlay Transplant for Limbal Stem Cell Deficiency

Phase 1

Recruiting

Led By Stephen Kaufman, MD

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 180 days following intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial focuses on treating LSCD (a blinding disease) by transplanting a naturally occurring basement membrane (DM) to replace the limbal niche, which may result in corneal re-epithelialization & prevent blindness.

Who is the study for?

This trial is for people with Limbal Stem Cell Deficiency (LSCD), a condition that can cause blindness, who have significant vision loss (20/100 or worse). It's suitable for those with partial LSCD affecting less than 75% of the corneal surface and those with more severe cases involving over 75%, experiencing frequent erosions or persistent defects despite treatment.

What is being tested?

The study tests transplanting Descemet's Membrane (DM) onto the eye's surface as a potential new treatment. DM may serve as a replacement 'niche' to support limbal stem cells in patients with partial or near-total LSCD, aiming to promote healing and improve vision.

What are the potential side effects?

Potential side effects are not explicitly listed but could include typical risks associated with eye surgery such as infection, inflammation, irritation, discomfort, changes in vision, and rejection of the transplanted material.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 180 days following intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~180 days following intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 days following intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Corneal Epitheliopathy on Slit Lamp Examination

Corneal Epitheliopathy on Slit Lamp Photography

Corneal Neovascularization on Slit Lamp Examination

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Visually significant partial LSCDExperimental Treatment1 Intervention

Patient with visually significant partial LSCD, as defined by a best corrected visual acuity of 20/100 or less, and partial LSCD on slit lamp exam with at least 25% of the limbus intact or at least 25% of the corneal surface covered with corneal epithelium will be enrolled in the first arm.

Group II: Total/near-total LSCD with recurrent or persistent epithelial defects (PED)Experimental Treatment1 Intervention

Patient with visually significant total LSCD, as defined by a best corrected visual acuity of 20/100 or less, and total LSCD on slit lamp exam with over 25% of the limbus intact or less than 25% of the corneal surface covered with corneal epithelium; and a history of a persistent epithelial defect that has persisted over 2 weeks despite maximal medical therapy, or a history of recurrent epithelial erosions that occur more frequently than once a month; will be enrolled in the second arm.

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