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Biological Membrane
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
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Corneal Epitheliopathy on Slit Lamp Examination
Corneal Epitheliopathy on Slit Lamp Photography
Corneal Neovascularization on Slit Lamp Examination
+6 moreTrial 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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Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,381 Previous Clinical Trials
1,588,955 Total Patients Enrolled
Stephen Kaufman, MDPrincipal InvestigatorUniversity of Minnesota
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to make medical decisions for myself.My eye condition affects less than 75% of the corneal surface and my vision is 20/100 or worse.I have severe eye surface damage with frequent pain or vision worse than 20/100 despite treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Visually significant partial LSCD
- Group 2: Total/near-total LSCD with recurrent or persistent epithelial defects (PED)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any current opportunities for people to participate in this experiment?
"Clinicaltrials.gov affirms that this trial, which was initiated on July 1st 2023 and last updated June 15th 2023 is no longer seeking participants. Nevertheless, there are still 12 medical studies currently recruiting individuals for their trials."
Answered by AI
What safety implications accompany Visually significant partial LSCD?
"There is little prior evidence of safety and efficacy, thus Visually Significant Partial LSCD was assigned a score of 1 in our estimation."
Answered by AI
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