Chemical Burn, Limbal Stem Cell Deficiency, Ocular Cicatricial Pemphigoid, Stevens-johnson Syndrome
Conditions
Keywords
Limbal stem cell deficiency, Cultivated oral mucosal cell sheet transplantation, Ocular surface reconstruction
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 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 1. patient with eye which has limbal stem cell deficiency and conjunctivalization of cornea 2. patient who shows no improvement after limbal tissue or amniotic membrane transplantation, or who has difficulty in receiving long-term immunosuppressive treatment 3. patient who agree this clinical trial 4. patient with the eyes in which best corrected visual acuity is less than counting finger 5. patient who is older than sixteen year old Exclusion criteria 1. patient who has relevant corneal transparency 2. patient who is on the pregnancy or has a plan of pregnancy within 1 year 3. patient who has corneal infection 4. patient who has diagnosis of HBV, HCV, HIV, syphilis 5. patinet who has past medial history of antinal, myocardial infarction, heart failure, arrhythmia, brain stroke, cerebrovascular disease 6. patient who has malignancy 7. 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)
Interventions
BIOLOGICALcultivated oral mucosal epithelial sheet transplantation
Autologous cultivated oral mucosal epithelial cell sheet transplantation using oral mucosal adult stem cells in the patients with intractable corneal limbal deficiency
Sponsors
Ministry of Health & Welfare, Korea
Seoul National University Hospital
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. patient with eye which has limbal stem cell deficiency and conjunctivalization of cornea 2. patient who shows no improvement after limbal tissue or amniotic membrane transplantation, or who has difficulty in receiving long-term immunosuppressive treatment 3. patient who agree this clinical trial 4. patient with the eyes in which best corrected visual acuity is less than counting finger 5. patient who is older than sixteen year old
Exclusion criteria
1. patient who has relevant corneal transparency 2. patient who is on the pregnancy or has a plan of pregnancy within 1 year 3. patient who has corneal infection 4. patient who has diagnosis of HBV, HCV, HIV, syphilis 5. patinet who has past medial history of antinal, myocardial infarction, heart failure, arrhythmia, brain stroke, cerebrovascular disease 6. patient who has malignancy 7. patient who shows hypersensitivity to bovine protein.
Countries
South Korea
Contacts
Primary ContactMee Kum Kim, MD, PhD
Backup ContactYu Jeong Kim, MD
Outcome results
None listed