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Ocular Surface Reconstruction With Cultivated Autologus Mucosal Epithelial Transplantation

NCT ID: NCT01942421

Last Updated: 2013-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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

Conditions

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Ocular Surface Disease

Keywords

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Limbal deficiency Cultivated limbal transplantation Ex vivo limbal transplantation Cultivated autologous mucosal epithelial transplantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cultivated mucosal epithelial transplant

Cultivated mucosal epithelial transplantaion to limbal deficiency patients

Group Type EXPERIMENTAL

Cultivated mucosal epithelial transplantation

Intervention Type PROCEDURE

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

Interventions

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Cultivated mucosal epithelial transplantation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Pinnita Prabhasawat

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pinnita Prabhasawat, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Pinnita Prabhasawat, MD

Bangkok, Thailand, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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639/2551(EC2)

Identifier Type: -

Identifier Source: org_study_id