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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
Sponsor:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Symblepharon Procedure: Autologous Ex Vivo Conjunctival for Symblepharon Transplantation Procedure: Ex Vivo Conjunctival for Symblepharon Transplantation Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2008
Primary Completion Date : November 2008
Estimated Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Reconstruction of Ocular surface in patients with symblepharon [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Re - reconstruction of Ocular surface in patients with symblepharon [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with ocular surface disorders, e.g. symblepharon
  • Indications for surgery will be the presence of ocular surface symptoms in the affected eye, loss of visual acuity from visual axis obscuration or irregular astigmatism, or cosmesis.
  • Only one eye of a patient will be eligible for study entry.
  • Patients who are adult males and females who are aged 16 or older, and are considered mentally sound
  • Patients who are willing to undergo long-term follow-up, as outlined in this protocol
  • Patients who have signed an informed consent form that has been approved by the SNEC Ethics Committee.

Exclusion Criteria:

  • Patients less than 16 years of age
  • Patients who are incapable, either by law or of mental state, of giving consent in their own right
  • Patients who are either unable or unwilling to keep scheduled appointments and adhere to the other aspects of the protocol
  • Patients who are pregnant or breastfeeding
  • Patients with a history of drug allergy
  • Patients who have received an investigational drug within 28 days preceding surgery
  • Patients with intraocular pressure over 21 mmHg or history of ocular hypertension or glaucoma
  • Patients who are documented to be steroid responders
More Information

Responsible Party: Jose Alvaro Pereira Gomes, UNIFESP, SAO PAULO, SP, BRAZIL
ClinicalTrials.gov Identifier: NCT00799526     History of Changes
Other Study ID Numbers: 1075/08
First Posted: December 1, 2008    Key Record Dates
Last Update Posted: December 1, 2008
Last Verified: November 2008

Keywords provided by Federal University of São Paulo:
Ex Vivo Conjunctival Epithelial Cell
Transplantation