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

NCT ID: NCT00491959

Last Updated: 2010-05-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2010-04-30

Brief Summary

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.

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.

Conditions

Limbal Insufficiency; Symblepharon

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Cultured oral mucosa cell sheet transplantation

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.

Intervention Type: PROCEDURE

Other Intervention Names

oral mucosal cell sheets; Therapeutic contact lenses

Eligibility Criteria

Inclusion Criteria

• patient with bilateral limbal insufficiency

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

National Taiwan University, Department of Ophthalmology

Principal Investigators

Fung-Rong Hu, MD

Role: STUDY_CHAIR

National Taiwan University Hospital

Locations

National Taiwan University Hospital, department of Ophthalmology

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

200701043D

Identifier Type: -

Identifier Source: org_study_id