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Efficacy of Cultivated Corneal Epithelial Stem Cell for Ocular Surface Reconstruction

This study has been completed.
Information provided by (Responsible Party):
Pinnita Prabhasawat, Mahidol University Identifier:
First received: November 8, 2010
Last updated: December 5, 2011
Last verified: December 2011
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.

Condition Intervention Phase
Severe Ocular Surface Damage Limbal Deficiency Procedure: Cultivated limbal transplantation Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Cultivated Corneal Epithelial Stem Cell for Ocular Surface Reconstruction

Further study details as provided by Pinnita Prabhasawat, Mahidol University:

Primary Outcome Measures:
  • Ocular surface status (signs of limbal deficiency and immunopathological markers) [ Time Frame: Three years ]

Enrollment: 19
Study Start Date: January 2008
Study Completion Date: November 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cultivated limbal transplantation Procedure: Cultivated limbal transplantation
Cultivated corneal epithelial stem cell transplantation. Autograft, Living related allograft, and Cadaveric allograft

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01237600

Pinnita Prabhasawat, MD
Bangkok, Thailand, 10300
Sponsors and Collaborators
Mahidol University
Principal Investigator: Pinnita Prabhasawat, MD Mahidol University
  More Information

Responsible Party: Pinnita Prabhasawat, Associate Professor, Mahidol University Identifier: NCT01237600     History of Changes
Other Study ID Numbers: 447/2550(EC2)
Study First Received: November 8, 2010
Last Updated: December 5, 2011

Keywords provided by Pinnita Prabhasawat, Mahidol University:
Ocular surface damage
Limbal deficiency
Cultivated corneal epithelial stem cell transplantation processed this record on September 21, 2017