Overview

This trial is active, not recruiting.

Condition ocular surface disease
Treatment cultivated mucosal epithelial transplantation
Phase phase 2/phase 3
Sponsor Mahidol University
Start date January 2008
End date June 2013
Trial size 20 participants
Trial identifier NCT01942421, 639/2551(EC2)

Summary

The purpose of this study is to elucidate the appropriate condition of developing cultivated autologous oral mucosal epithelial graft and evaluate the surgical outcome of transplantation of the cultivated cells in the patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Cultivated mucosal epithelial transplantaion to limbal deficiency patients
cultivated mucosal epithelial transplantation
cultivated autologous mucosal epithelium, then transplant to limbal stem cell deficiency patients.

Primary Outcomes

Measure
Ocular surface clinical and pathological status(signs of limbal deficiency and immunopathological markers)after the surgery
time frame: Three years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Bilateral limbal stem cell deficiency proved by specific clinical features and impression cytology Exclusion Criteria: - Age under 18 - Active ocular infection, Severe dry eye, Uncontrolled glaucoma - Immunocompromised host - Pregnancy

Additional Information

Official title Ocular Surface Reconstruction With Cultivated Autologus Mucosal Epithelial Transplantation.
Principal investigator Pinnita Prabhasawat, MD
Description Ocular surface damage caused by severe ocular surface diseases. 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. Ocular surface reconstruction with cultivated autologous mucosal epithelial transplantation is served to improve the surgical results of ocular surface reconstruction and decrease the use of immunosuppressive medications
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by Mahidol University.