Ignite Creation Date:
2025-12-24 @ 9:50 PM
Ignite Modification Date:
2026-02-20 @ 1:45 PM
Study NCT ID:
NCT02149732
Status:
AVAILABLE
Last Update Posted:
2016-04-20
First Post:
2014-05-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
An Investigator-initiated Trial (IIT) on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation in Corneal Limbal Deficiency Patients
Status:
AVAILABLE
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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)
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| MKKim | OTHER_GRANT | Ministry of Health & Welfare, Republic of Korea (HI11C1590) | View |