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Efficacy of Cultivated Corneal Epithelial Stem Cell for Ocular Surface Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01237600
Recruitment Status : Completed
First Posted : November 9, 2010
Last Update Posted : December 7, 2011
Information provided by (Responsible Party):
Pinnita Prabhasawat, Mahidol University

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
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
Study Start Date : January 2008
Actual Primary Completion Date : April 2011
Actual Study Completion Date : November 2011

Arm Intervention/treatment
Experimental: Cultivated limbal transplantation Procedure: Cultivated limbal transplantation
Cultivated corneal epithelial stem cell transplantation. Autograft, Living related allograft, and Cadaveric allograft

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01237600

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

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Responsible Party: Pinnita Prabhasawat, Associate Professor, Mahidol University Identifier: NCT01237600    
Other Study ID Numbers: 447/2550(EC2)
First Posted: November 9, 2010    Key Record Dates
Last Update Posted: December 7, 2011
Last Verified: December 2011
Keywords provided by Pinnita Prabhasawat, Mahidol University:
Ocular surface damage
Limbal deficiency
Cultivated corneal epithelial stem cell transplantation