Efficacy of Cultivated Corneal Epithelial Stem Cell for Ocular Surface Reconstruction

Limbal Deficiency Clinical Trial

Official title:

Efficacy of Cultivated Corneal Epithelial Stem Cell for Ocular Surface Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01237600
• Other study ID #: 447/2550(EC2)
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 8, 2010
• Last updated: December 5, 2011
• Start date: January 2008
• Est. completion date: November 2011

Study information

• Verified date: December 2011
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: November 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Limbal Deficiency
• Severe Ocular Surface Damage

Intervention

Procedure:
• Cultivated limbal transplantation
Cultivated corneal epithelial stem cell transplantation. Autograft, Living related allograft, and Cadaveric allograft

Locations

Country	Name	City	State
Thailand	Pinnita Prabhasawat, MD	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular surface status (signs of limbal deficiency and immunopathological markers)		Three years	Yes