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
  Purpose

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 Intervention Phase
Symblepharon
Procedure: Autologous Ex Vivo Conjunctival for Symblepharon Transplantation
Procedure: Ex Vivo Conjunctival for Symblepharon Transplantation
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Reconstruction of Ocular surface in patients with symblepharon [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Re - reconstruction of Ocular surface in patients with symblepharon [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: November 2008
Estimated Study Completion Date: November 2010
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   16 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Jose Alvaro Pereira Gomes, UNIFESP, SAO PAULO, SP, BRAZIL
ClinicalTrials.gov Identifier: NCT00799526     History of Changes
Other Study ID Numbers: 1075/08
Study First Received: November 28, 2008
Last Updated: November 28, 2008
Health Authority: Brazil: Ethics Committee

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

ClinicalTrials.gov processed this record on October 20, 2014