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Clinical Trials/NCT01237600
NCT01237600
Completed
Phase 2

Efficacy of Cultivated Corneal Epithelial Stem Cell for Ocular Surface Reconstruction

Mahidol University1 site in 1 country19 target enrollmentJanuary 2008

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Severe Ocular Surface Damage
Sponsor
Mahidol University
Enrollment
19
Locations
1
Primary Endpoint
Ocular surface status (signs of limbal deficiency and immunopathological markers)
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2008
End Date
November 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pinnita Prabhasawat

Associate Professor

Mahidol University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Ocular surface status (signs of limbal deficiency and immunopathological markers)

Time Frame: Three years

Study Sites (1)

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