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Efficacy of Cultivated Corneal Epithelial Stem Cell for Ocular Surface Reconstruction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pinnita Prabhasawat, Mahidol University
ClinicalTrials.gov Identifier:
NCT01237600
First received: November 8, 2010
Last updated: December 5, 2011
Last verified: December 2011
History of Changes
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Cultivated Corneal Epithelial Stem Cell for Ocular Surface Reconstruction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mahidol University:

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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01237600

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

No publications provided

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

Keywords provided by Mahidol University:
Ocular surface damage
Limbal deficiency
Cultivated corneal epithelial stem cell transplantation

ClinicalTrials.gov processed this record on May 23, 2013