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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00799526
Study type Interventional
Source Federal University of São Paulo
Contact
Status Active, not recruiting
Phase Phase 1
Start date November 2008
Completion date November 2010

See also
  Status Clinical Trial Phase
Terminated NCT00491959 - The Application of Oral Mucosal Epithelial Cell Sheets Cultivated on Amino Membrane in Patients Suffering From Corneal Stem Cell Insufficiency or Symblepharon. Phase 1
Completed NCT01178242 - Salivary Gland Transplantation in the Treatment of Dry Eye in Patients With Stevens-Johnson Syndrome. N/A