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NCT04995926
Labial Mucosal Epithelium Grafting for Corneal Limbus Substitution
NA trial testing Labial mucosal epithelium grafting for corneal limbus substitution in Limbal Stem-cell Deficiency in 20 participants. Currently enrolling.
30 May 2024
Quick facts
| Lead sponsor | The S.N. Fyodorov Eye Microsurgery State Institution |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 July 2021 |
| Primary completion | 30 May 2024 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- Labial mucosal epithelium grafting for corneal limbus substitution
Conditions studied
- Limbal Stem-cell Deficiency — all drugs for Limbal Stem-cell Deficiency →
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):
-
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT04995926
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04995926 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The S.N. Fyodorov Eye Microsurgery State Institution
- Last refreshed: 23 April 2024
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