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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Federal University of São Paulo.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00799526
First received: November 28, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted

November 28, 2008
November 28, 2008
November 2008
November 2008   (final data collection date for primary outcome measure)
Reconstruction of Ocular surface in patients with symblepharon [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Re - reconstruction of Ocular surface in patients with symblepharon [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Transplant of Epithelium Conjunctival Human Autologous Cultivated ex Vivo in Amniotic Membrane for the Treatment of Symblepharon
Not Provided

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.

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Symblepharon
  • 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.
Experimental: Ex Vivo Transplantation
Autologous Ex Vivo Conjunctival Epithelial Cell Expansion for Symblepharon Transplantation
Interventions:
  • Procedure: Autologous Ex Vivo Conjunctival for Symblepharon Transplantation
  • Procedure: Ex Vivo Conjunctival for Symblepharon Transplantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
10
November 2010
November 2008   (final data collection date for primary outcome measure)

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
Both
16 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00799526
1075/08
Yes
Jose Alvaro Pereira Gomes, UNIFESP, SAO PAULO, SP, BRAZIL
Federal University of São Paulo
Not Provided
Not Provided
Federal University of São Paulo
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP