Clinical Trial on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation

Sponsor

Seoul National University Hospital (Other)

Overall Status

Available

CT.gov ID

NCT02149732

Collaborator

Ministry of Health & Welfare, Korea (Other)

Locations

Duration (Months)

Study Details

Study Description

Brief Summary

To investigate the effect of ocular surface reconstruction and assess the safety in cultivated oral mucosal epithelial cell sheet transplantation (COMET) regarding patients with cicatricial change of ocular surface.

Condition or Disease	Intervention/Treatment	Phase
Limbal Stem Cell Deficiency Stevens-johnson Syndrome Ocular Cicatricial Pemphigoid Chemical Burn	Biological: cultivated oral mucosal epithelial sheet transplantation

Detailed Description

Interventional study for treatment of patients with cicatricial change of ocular surface.

Single Group: (Limbal stem cell deficiency group)

Treatment: After cultivating autologous Oral mucosal epithelial cell sheet, the sheet will be transplanted to the ocular surface of the patients

Inclusion criteria

patient with eye which has limbal stem cell deficiency and conjunctivalization of cornea
patient who shows no improvement after limbal tissue or amniotic membrane transplantation, or who has difficulty in receiving long-term immunosuppressive treatment
patient who agree this clinical trial
patient with the eyes in which best corrected visual acuity is less than counting finger
patient who is older than sixteen year old

Exclusion criteria

patient who has relevant corneal transparency
patient who is on the pregnancy or has a plan of pregnancy within 1 year
patient who has corneal infection
patient who has diagnosis of HBV, HCV, HIV, syphilis
patinet who has past medial history of antinal, myocardial infarction, heart failure, arrhythmia, brain stroke, cerebrovascular disease
patient who has malignancy
patient who shows hypersensitivity to bovine protein.

Primary outcome Epithelization of corneal surface (6 months after cell sheet transplantation)

Secondary outcome Visual acuity (6 months after cell sheet transplantation)

Study Design

Study Type:

Expanded Access

Official Title:

An Investigator-initiated Trial (IIT) on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation in Corneal Limbal Deficiency Patients

Study Start Date :

May 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patient with eye which has limbal stem cell deficiency and conjunctivalization of cornea
patient who shows no improvement after limbal tissue or amniotic membrane transplantation, or who has difficulty in receiving long-term immunosuppressive treatment
patient who agree this clinical trial
patient with the eyes in which best corrected visual acuity is less than counting finger
patient who is older than sixteen year old

Exclusion Criteria:

patient who has relevant corneal transparency
patient who is on the pregnancy or has a plan of pregnancy within 1 year
patient who has corneal infection
patient who has diagnosis of HBV, HCV, HIV, syphilis
patinet who has past medial history of antinal, myocardial infarction, heart failure, arrhythmia, brain stroke, cerebrovascular disease
patient who has malignancy
patient who shows hypersensitivity to bovine protein.