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NCT04995926

Labial Mucosal Epithelium Grafting for Corneal Limbus Substitution

Recruiting now NA Last updated 23 April 2024
What this trial tests

NA trial testing Labial mucosal epithelium grafting for corneal limbus substitution in Limbal Stem-cell Deficiency in 20 participants. Currently enrolling.

Timeline
1 July 2021
Primary endpoint
30 May 2024
31 December 2025

Quick facts

Lead sponsorThe S.N. Fyodorov Eye Microsurgery State Institution
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment20
Start date1 July 2021
Primary completion30 May 2024
Estimated completion31 December 2025
Sites1 location across Russia

Drugs / interventions tested

Conditions studied

Sponsor

The S.N. Fyodorov Eye Microsurgery State Institution

Who can join

Adults 18 to 70, any sex, with Limbal Stem-cell Deficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Earlier approaches for cornea reepithelization in patients with bilateral LSCD included allogeneic corneal limbus grafting from postmortem donor or livingrelated relatives with concomitant systemic immunosuppression (Cheung and Holland, 2017) and cultivated oral mucosal epithelial transplantation (COMET) (Nishida et al., 2004). The novel surgical technique for corneal re-epithelization were described by Liu et al. (2011) and Choe et al. (2019). In both clinical studies, the autologous labial mucosal epithelium graft was transplanted as a surrogate corneal limbus for purpose of treatment the LSCD. Authors reported positive outcomes in terms of anatomical success and corneal status improvement. The purpose of the study is to evaluate the feasibility of the novel surgical intervention in clinical use.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Therapeutic Strategies for Restoring Perturbed Corneal Epithelial Homeostasis in Limbal Stem Cell Deficiency: Current Trends and Future Directions.
    Masood F, Chang JH, Akbar A, Song A, et al · · 2022 · cited 26× · PMID 36291115 · DOI 10.3390/cells11203247
  2. Regenerative treatment of ophthalmic diseases with stem cells: Principles, progress, and challenges.
    Niu Y, Ji J, Yao K, Fu Q. · · 2024 · cited 25× · PMID 38586868 · DOI 10.1016/j.aopr.2024.02.001
  3. Targeting limbal epithelial stem cells: master conductors of corneal epithelial regeneration from the bench to multilevel theranostics.
    Li S, Sun H, Chen L, Fu Y. · · 2024 · cited 16× · PMID 39198892 · DOI 10.1186/s12967-024-05603-y
  4. Understanding the cellular dynamics, engineering perspectives and translation prospects in bioprinting epithelial tissues.
    Derman ID, Moses JC, Rivera T, Ozbolat IT. · · 2025 · cited 7× · PMID 39386221 · DOI 10.1016/j.bioactmat.2024.09.025
  5. Tackling visual impairment: emerging avenues in ophthalmology.
    Lin F, Su Y, Zhao C, Akter F, et al · · 2025 · cited 4× · PMID 40357281 · DOI 10.3389/fmed.2025.1567159
  6. Diagnostic Algorithm for Surgical Management of Limbal Stem Cell Deficiency.
    Malyugin B, Kalinnikova S, Isabekov R, Ostrovskiy D, et al · · 2023 · cited 2× · PMID 36673009 · DOI 10.3390/diagnostics13020199

Verify or expand the search:

Other recruiting trials for Limbal Stem-cell Deficiency

Currently open trials in the same condition.

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Data sources for this page

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