Clinical Trial: Clinical Trial on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation
Study Status: Available
Recruit Status: Available
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
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.
Detailed Summary:
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
Sponsor: Seoul National University Hospital
Current Primary Outcome:
Original Primary Outcome: Epithelization of corneal surface [ Time Frame: 6 months after cell sheet transplantation ]
Epithelization area in total corneal surface (%)
= Epithelized corneal surface area / Total corneal surface area x 100 (%)
Corneal diameter = R Diameter in non-epithelized area = r Epithelized corneal surface area = 3.14x(R2-r2)/4 Total corneal surface area = 3.14xR2/4
Current Secondary Outcome:
Original Secondary Outcome: Best Corrected Visual Acuity (BCVA) [ Time Frame: 6 months after cell sheet transplantation ]
Information By: Seoul National University Hospital
Dates:
Date Received: May 14, 2014
Date Started: May 2014
Date Completion: December 2016
Last Updated: April 18, 2016
Last Verified: April 2016