Treatment for Limbal Stem Cell Deficiency using Descemet's Membrane
Treatment of Limbal Stem Cell Deficiency With Descemet's Membrane
PHASE1 · University of Minnesota · NCT05909735
This study is testing a new way to treat corneal blindness caused by Limbal Stem Cell Deficiency by using a special corneal onlay to see if it can improve vision for people with this condition.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Minnesota (other) |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05909735 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to treat Limbal Stem Cell Deficiency (LSCD) by transplanting a Descemet's Membrane corneal onlay. LSCD is a significant cause of corneal blindness, and current treatments are inadequate. The study will involve patients with either partial or total LSCD, assessing the effectiveness of the onlay in restoring corneal health and vision. The trial will evaluate the safety and efficacy of this innovative approach in a controlled setting.
Who should consider this trial
Good fit: Ideal candidates include individuals with partial or total LSCD who have visually significant impairment and have not responded to conventional therapies.
Not a fit: Patients who are pregnant, prisoners, or unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve vision and quality of life for patients suffering from LSCD.
How similar studies have performed: While there have been limited studies on similar approaches, this specific use of Descemet's Membrane for LSCD treatment is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Arm 1: * partial LSCD (involving less than 75% of the limbus, or \<75% of the corneal surface) * Visually significant (best-corrected visually acuity 20/100 or worse) Arm 2: * total/near-total LSCD with recurrent erosions or PEDs (involving more than 75% of the limbus, or more than 75% of the corneal surface) * Visually significant (best-corrected visually acuity 20/100 or worse) PLUS * Persistent epithelial defects last \>2 weeks despite maximal medical therapy OR * Recurrent erosions occuring at least once every month Exclusion Criteria: * Pregnant women * Prisoners (vulnerable population) * Adults lacking capacity to consent (vulnerable population) * Adults unable to sign consent due to non-english speaking or illiterate (vulnerable population)
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Stephen Kaufman, MD — University of Minnesota
- Study coordinator: Meaghyn Kramer, BA
- Email: krame706@umn.edu
- Phone: 612-625-4108
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: Limbal Stem-cell Deficiency, Congenital Aniridia, congenital aniridia, limbal stem cell deficiency, Descemet's Membrane