Skip to content

Efficacy of Cultivated Corneal Epithelial Stem Cell for Ocular Surface Reconstruction

Efficacy of Cultivated Corneal Epithelial Stem Cell for Ocular Surface Reconstruction

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01237600
Enrollment
19
Registered
2010-11-09
Start date
2008-01-31
Completion date
2011-11-30
Last updated
2011-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Limbal Deficiency, Severe Ocular Surface Damage

Keywords

Ocular surface damage, Limbal deficiency, Cultivated corneal epithelial stem cell transplantation

Brief summary

The purpose of this study is to elucidate the appropriate condition of developing cultivated corneal epithelial graft and evaluate the surgical outcome of transplantation of the cultivated corneal epithelial stem cell in the patients.

Detailed description

Ocular surface damage caused by severe ocular surface diseases, particularly thermal and chemical burn or Stevens-Johnson syndrome result in corneal epithelial defect, corneal vascularization, corneal conjunctivalization and loss of transparency. Corneal limbal stem cell transplantation has been demonstrated to improve the outcome of ocular surface reconstruction. However, the conventional management of allograft limbal transplantation generally has unsatisfactory outcome because of high risk of rejection and requires long-life immunosuppressive medications.

Interventions

PROCEDURECultivated limbal transplantation

Cultivated corneal epithelial stem cell transplantation. Autograft, Living related allograft, and Cadaveric allograft

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Unilateral/Bilateral limbal stem cell deficiency proved by specific clinical features and impression cytology result

Exclusion criteria

* Age under 18 * Active ocular infection, Severe dry eye, Uncontrolled glaucoma * Immunocompromised host * Pregnancy

Design outcomes

Primary

MeasureTime frame
Ocular surface status (signs of limbal deficiency and immunopathological markers)Three years

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026