The Application of Oral Mucosal Epithelial Cell Sheets Cultivated on Amino Membrane in Patients Suffering From Corneal Stem Cell Insufficiency or Symblepharon.

Phase 1 Study of Oral Mucosal Epithelial Cell Sheets in Patients Suffering From Corneal Stem Cell Insufficiency or Symblepharon

Since cultivated autologous oral mucosal epithelial sheets on amniotic membrane have been reported to have good clinical results in treating patients with ocular surface disorders in both human or animal studies, and such technique has not been used in our hospital, the main purpose of this study is to use these cell sheets to treat patients with severe surface disorders, which include limbal insufficiency induced corneal surface problem, and symblepharon caused by severe conjunctival epithelial insufficiency. We will first choose patients who meet the surgical criteria, and these patients need to receive dental examination three months before surgery. Two weeks before transplantation, the oral mucosa tissue will be obtained by a dentist and the oral mucosal epithelial cell sheets will be cultivated on amniotic membrane until reaching confluency and stratification. During the transplantation surgery, the abnormal fibrovascular tissues on the ocular surface will be removed. The areas of symblepharon will also be released. The cultivated oral mucosal cell sheets will be transplanted on the denuded corneal surface or the scleral surface of the symblepharon area. Therapeutic contact lenses will be applied after surgery. After operation, the patients will be admitted for about two weeks. After discharge, the patients need to receive regular follow up weekly during the first two months, followed by biweekly follow up until postoperative 6 months. Afterward, the patients need to receive monthly follow up until postoperative 2 years. During the follow up, the data of the patients' visual acuity, intraocular pressure, slit lamp biomicroscopic findings, and in vivo confocal microscopic data will be obtained. The project plans to start from July 1st 2007 until June 30th 2010. We plan to enroll totally 20 patients.

Study Overview

• Status: Terminated
• Conditions: Symblepharon; Limbal Insufficiency
• Intervention / Treatment: Procedure: Cultured oral mucosa cell sheet transplantation

Detailed Description

Cultivated autologous oral mucosal epithelial sheets on amniotic membrane have been reported to have good clinical results in treating patients with ocular surface disorders in both human or animal studies, and such technique has not been used in our hospital, the main purpose of this study is to use these cell sheets to treat patients with severe surface disorders, which include limbal insufficiency induced corneal surface problem, and symblepharon caused by severe conjunctival epithelial insufficiency. We will first choose patients who meet the surgical criteria, and these patients need to receive dental examination three months before surgery. Two weeks before transplantation, the oral mucosa tissue will be obtained by a dentist and the oral mucosal epithelial cell sheets will be cultivated on amniotic membrane until reaching confluency and stratification. During the transplantation surgery, the abnormal fibrovascular tissues on the ocular surface will be removed. The areas of symblepharon will also be released. The cultivated oral mucosal cell sheets will be transplanted on the denuded corneal surface or the scleral surface of the symblepharon area. Therapeutic contact lenses will be applied after surgery. After operation, the patients will be admitted for about two weeks. After discharge, the patients need to receive regular follow up weekly during the first two months, followed by biweekly follow up until postoperative 6 months. Afterward, the patients need to receive monthly follow up until postoperative 2 years. During the follow up, the data of the patients' visual acuity, intraocular pressure, slit lamp biomicroscopic findings, and in vivo confocal microscopic data will be obtained. The project plans to start from July 1st 2007 until June 30th 2010. We plan to enroll totally 20 patients.

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 10047
    • National Taiwan University Hospital, department of Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patient with bilateral limbal insufficiency

Exclusion Criteria:

• ocular diseases other than limbal insufficiency glaucoma diseases of retina or optic nerve

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
condition of ocular surface	6 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Chair: Fung-Rong Hu, MD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: June 23, 2007
• First Submitted That Met QC Criteria: June 23, 2007
• First Posted (Estimate): June 26, 2007

Study Record Updates

• Last Update Posted (Estimate): May 4, 2010
• Last Update Submitted That Met QC Criteria: May 3, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: transplantation; cornea; ocular surface; oral mucosa; limbal insufficiency
• Other Study ID Numbers: 200701043D