Efficacy of Cultivated Corneal Epithelial Stem Cell for Ocular Surface Reconstruction

• Sponsor: Mahidol University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01237600
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Arm: 1
• Duration (Months): 46
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: N/A
• 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: Jan 1, 2008
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Ocular surface status (signs of limbal deficiency and immunopathological markers) [Three years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Locations

	Site	City	State	Country	Postal Code
1	Pinnita Prabhasawat, MD	Bangkok		Thailand	10300

Sponsors and Collaborators

• Mahidol University

Investigators

• Principal Investigator: Pinnita Prabhasawat, MD, Mahidol University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pinnita Prabhasawat, Associate Professor, Mahidol University
• ClinicalTrials.gov Identifier: NCT01237600
• Other Study ID Numbers: 447/2550(EC2)
• First Posted: Nov 9, 2010
• Last Update Posted: Dec 7, 2011
• Last Verified: Dec 1, 2011

• Keywords provided by Pinnita Prabhasawat, Associate Professor, Mahidol University: Ocular surface damage; Limbal deficiency; Cultivated corneal epithelial stem cell transplantation

Study Results

No Results Posted as of Dec 7, 2011