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Ocular Surface Reconstruction With Cultivated Autologus Mucosal Epithelial Transplantation

Phase 2
Conditions
Ocular Surface Disease
Interventions
Procedure: Cultivated mucosal epithelial transplantation
Registration Number
NCT01942421
Lead Sponsor
Mahidol University
Brief Summary

The purpose of this study is to elucidate the appropriate condition of developing cultivated autologous oral mucosal epithelial graft and evaluate the surgical outcome of transplantation of the cultivated cells in the patients.

Detailed Description

Ocular surface damage caused by severe ocular surface diseases. 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. Ocular surface reconstruction with cultivated autologous mucosal epithelial transplantation is served to improve the surgical results of ocular surface reconstruction and decrease the use of immunosuppressive medications

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
20
Inclusion Criteria
  • Bilateral limbal stem cell deficiency proved by specific clinical features and impression cytology
Exclusion Criteria
  • Age under 18
  • Active ocular infection, Severe dry eye, Uncontrolled glaucoma
  • Immunocompromised host
  • Pregnancy

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Cultivated mucosal epithelial transplantCultivated mucosal epithelial transplantationCultivated mucosal epithelial transplantaion to limbal deficiency patients
Primary Outcome Measures
NameTimeMethod
Ocular surface clinical and pathological status(signs of limbal deficiency and immunopathological markers)after the surgeryThree years
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Pinnita Prabhasawat, MD

🇹🇭

Bangkok, Thailand

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