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Status unknownNCT00799526Updated Dec 1, 2008

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

A Phase 1 interventional study of Autologous Ex Vivo Conjunctival for Symblepharon Transplantation and Ex Vivo Conjunctival for Symblepharon Transplantation in Symblepharon, sponsored by Federal University of São Paulo. Status unknown. Open to participants aged 16 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-12-01.

Sponsored by Federal University of São Paulo · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2008), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
16 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Symblepharon

Keywords

  • Ex Vivo Conjunctival Epithelial Cell
  • Transplantation
03

In context

Lead sponsor

Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Ex Vivo Transplantation

    Autologous Ex Vivo Conjunctival Epithelial Cell Expansion for Symblepharon Transplantation

    Procedure: Autologous Ex Vivo Conjunctival for Symblepharon Transplantation · Procedure: Ex Vivo Conjunctival for Symblepharon Transplantation

Interventions

  • ProcedureAutologous Ex Vivo Conjunctival for Symblepharon Transplantation

    Safety and efficacy of conjunctival ex vivo for reconstruction of the ocular surface.

  • ProcedureEx 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.

06

What researchers measure

Primary outcomes

  1. Reconstruction of Ocular surface in patients with symblepharon

    Time frame: 6 months

Secondary outcomes

  1. Re - reconstruction of Ocular surface in patients with symblepharon

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00799526
Lead sponsor
Federal University of São Paulo
First posted
Dec 1, 2008
Start date
Nov 2008
Primary completion
Nov 2008
Completion
Nov 2010 (estimated)
Last update
Dec 1, 2008

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2008. You cannot join it, but the record below documents what was studied.

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