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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Expanded Access
Eligible Ages	16 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02149732
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Seoul National University Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Mee Kum Kim, MD, PhD
Principal Investigator Affiliation	Department of Ophthalmology, Seoul National University College of Medicine
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Available
Countries	Korea, Republic of
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Limbal Stem Cell Deficiency, Stevens-johnson Syndrome, Ocular Cicatricial Pemphigoid, Chemical Burn

Additional Details

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)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Seoul National University Hospital, Seoul, Korea, Republic of

Status

Available

Address

Seoul National University Hospital

Seoul, , 110-744

Site Contact

Mee Kum Kim, MD, PhD

[email protected]

82-10-6277-0798

Seoul National Unversity Hospital, Seoul, Korea, Republic of