Brief Title
Clinical Trial on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation
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 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)
Study Type
Expanded Access
Condition
Limbal Stem Cell Deficiency
Intervention
cultivated oral mucosal epithelial sheet transplantation
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Start Date
May 2014
Completion Date
December 2016
Primary Completion Date
December 2016
Eligibility 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.
Gender
All
Ages
16 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Mee Kum Kim, MD, PhD, 82-10-6277-0798, [email protected]
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT02149732
Organization ID
COMET trial
Secondary IDs
MKKim
Responsible Party
Sponsor
Study Sponsor
Seoul National University Hospital
Collaborators
Ministry of Health & Welfare, Korea
Study Sponsor
Mee Kum Kim, MD, PhD, Principal Investigator, Department of Ophthalmology, Seoul National University College of Medicine
Verification Date
April 2016