NCT01123044

Transplantation of Cultivated Corneal Epithelial Sheet in Patients With Ocular Surface Disease

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Ministry of Health, Malaysia · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to assess if transplantation of cultivated corneal epithelial stem cells could restore vision in patients with severe ocular surface disorder with a favourable safety profile that warrants further comparative study.

Detailed description

Objectives: Efficacy: To determine the efficacy of cultivated corneal epithelial stem cells as a treatment for patients with severe ocular surface disorder. The corneal limbal epithelial stem cell transplant (CLET) successful outcome will be measured by improvement of vision, maintenance of corneal re-epithelisation with absence of recurrence of surface disease and subjective improvement of symptoms.

Conditions

• Eye Injury

Interventions

Type	Name	Description
BIOLOGICAL	conservative	Undergo autologous transplantation of limbal epithelial cells cultured on amniotic membrane
PROCEDURE	Medical Therapy	Under usual care treatment

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-06-01
• Completion: 2012-09-01
• First posted: 2010-05-14
• Last updated: 2011-07-08

Locations

1 site across 1 country: Malaysia