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Efficacy of Cultivated Corneal Epithelial Stem Cell for Ocular Surface Reconstruction

NCT ID: NCT01237600

Last Updated: 2011-12-07

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

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-11-30

Brief Summary

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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

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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.

Conditions

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Severe Ocular Surface Damage Limbal Deficiency

Keywords

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

Group Type EXPERIMENTAL

Cultivated limbal transplantation

Intervention Type PROCEDURE

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

Interventions

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Cultivated limbal transplantation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
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

Site Status

Countries

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Thailand

Other Identifiers

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447/2550(EC2)

Identifier Type: -

Identifier Source: org_study_id