NCT02149732

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

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

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Limbal Stem Cell Deficiency
• Stevens-johnson Syndrome
• Ocular Cicatricial Pemphigoid
• Chemical Burn

Interventions

Type	Name	Description
BIOLOGICAL	cultivated 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

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2014-05-29
• Last updated: 2016-04-20

Locations

2 sites across 1 country: South Korea