Ocular Surface Reconstruction With Cultivated Autologus Mucosal Epithelial Transplantation

Phase 3UnknownNCT01942421

Mahidol University20 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ocular Surface Disease

Interventions

Cultivated mucosal epithelial transplantationPROCEDURE

cultivated autologous mucosal epithelium, then transplant to limbal stem cell deficiency patients.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Pinnita Prabhasawat, MD

Bangkok, Thailand, Thailand

Outcomes

Primary Outcomes

Ocular surface clinical and pathological status(signs of limbal deficiency and immunopathological markers)after the surgery

Time frame: Three years

Data from ClinicalTrials.gov

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