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

NCT00799526 | Unknown Phase 1 DMC

• 1 other identifier: 1075/08
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Symblepharon

Keywords

Ex Vivo Conjunctival Epithelial Cell; Transplantation

Outcome Measures

Primary Outcomes (1)

• Reconstruction of Ocular surface in patients with symblepharon

  6 months

Secondary Outcomes (1)

• Re - reconstruction of Ocular surface in patients with symblepharon

  6 months

Study Arms (1)

Ex Vivo Transplantation

EXPERIMENTAL

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

Autologous Ex Vivo Conjunctival for Symblepharon Transplantation PROCEDURE

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

Ex Vivo Transplantation

Ex Vivo Conjunctival for Symblepharon Transplantation PROCEDURE

The safety and efficacy of human conjunctival epithelial autologous cultivated ex vivo for reconstruction of the ocular surface with symblepharon.

Ex Vivo Transplantation

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 28, 2008
• First Posted: December 1, 2008
• Study Start: November 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2010
• Last Updated: December 1, 2008

Record last verified: 2008-11