NCT00799526

Transplant of Epithelium Conjunctival Human Autologous Cultivated ex Vivo in Amniotic Membrane for the Treatment of Symblepharon

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 16 Years – 90 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the safety and efficacy of human conjunctival epithelial autologous cultivated ex vivo for reconstruction of the ocular surface in patients with symblepharon.

Detailed description

10 patients will be included from 16 to 90 years with presence of symblepharon, what have been already subjected to proceedings of reconstruction of the ocular surface without success and to present conjunctival healthy. In the place of biopsy and after the surgery of the patient one will be applied ointment with antibiotic and corticoid to minimize the inflammatory effects. The fragments will be transported even it laboratory of Molecular Biology of the advanced Centre of Ocular Surface where it will be prosecuted by means of technique sterile under laminating flow. The conjunctival epithelias cells will be put on the amniotic membrane compartments of the plate of culture where the appropriate ways will be added. After 2 weeks the membranes colonized with epithelium conjunctival they will be subjected to the coloration and the cloth will be used for the surgery of reconstruction of the ocular surface. It will be carried out first us an evaluation ophthalmologic complete weekly, 2 months and then fortnightly up to the sixth month post-operative.

Conditions

• Symblepharon

Interventions

Type	Name	Description
PROCEDURE	Autologous Ex Vivo Conjunctival for Symblepharon Transplantation	Safety and efficacy of conjunctival ex vivo for reconstruction of the ocular surface.
PROCEDURE	Ex Vivo Conjunctival for Symblepharon Transplantation	The safety and efficacy of human conjunctival epithelial autologous cultivated ex vivo for reconstruction of the ocular surface with symblepharon.

Timeline

• Start date: 2008-11-01
• Primary completion: 2008-11-01
• Completion: 2010-11-01
• First posted: 2008-12-01
• Last updated: 2008-12-01