Transplant of Epithelium Conjunctival Human Autologous Cultivated ex Vivo in Amniotic Membrane for the Treatment of Symblepharon
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|ClinicalTrials.gov Identifier: NCT00799526|
Recruitment Status : Unknown
Verified November 2008 by Federal University of São Paulo.
Recruitment status was: Active, not recruiting
First Posted : December 1, 2008
Last Update Posted : December 1, 2008
Federal University of São Paulo
Information provided by:
Federal University of São Paulo
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.
|Condition or disease||Intervention/treatment||Phase|
|Symblepharon||Procedure: Autologous Ex Vivo Conjunctival for Symblepharon Transplantation Procedure: Ex Vivo Conjunctival for Symblepharon Transplantation||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||November 2008|
|Estimated Study Completion Date :||November 2010|
Experimental: Ex Vivo Transplantation
Autologous Ex Vivo Conjunctival Epithelial Cell Expansion for Symblepharon Transplantation
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.
Primary Outcome Measures :
- Reconstruction of Ocular surface in patients with symblepharon [ Time Frame: 6 months ]
Secondary Outcome Measures :
- Re - reconstruction of Ocular surface in patients with symblepharon [ Time Frame: 6 months ]
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