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

This study has been terminated.
(Due to unstalbe cell sheet quality. We didn't use this tech on patients.)
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00491959
First received: June 23, 2007
Last updated: May 3, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Limbal Insufficiency
Symblepharon
Procedure: Cultured oral mucosa cell sheet transplantation
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of Oral Mucosal Epithelial Cell Sheets in Patients Suffering From Corneal Stem Cell Insufficiency or Symblepharon

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • condition of ocular surface [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: September 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: 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.
    Other Names:
    • oral mucosal cell sheets
    • Therapeutic contact lenses
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient with bilateral limbal insufficiency

Exclusion Criteria:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00491959

Locations
Taiwan
National Taiwan University Hospital, department of Ophthalmology
Taipei, Taiwan, 10047
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Chair: Fung-Rong Hu, MD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Wei-Li Chen/Assistant Professor, National Taiwan University, Department of Ophthalmology
ClinicalTrials.gov Identifier: NCT00491959     History of Changes
Other Study ID Numbers: 200701043D
Study First Received: June 23, 2007
Last Updated: May 3, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
oral mucosa
limbal insufficiency
transplantation
cornea
ocular surface

Additional relevant MeSH terms:
Stress, Psychological
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 21, 2014