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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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2 May 2016 |
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Main ID: |
NCT02149732 |
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Date of registration:
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14/05/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical Trial on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation
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Scientific title:
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An Investigator-initiated Trial (IIT) on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation in Corneal Limbal Deficiency Patients |
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Date of first enrolment:
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May 2014 |
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Target sample size:
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Recruitment status: |
Available |
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URL:
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https://clinicaltrials.gov/show/NCT02149732 |
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Study type:
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Expanded Access |
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Study design:
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N/A
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Mee Kum Kim, MD, PhD |
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Address:
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Telephone:
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82-10-6277-0798 |
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Email:
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kmk9@snu.ac.kr |
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Affiliation:
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Name:
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Mee Kum Kim, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Ophthalmology, Seoul National University College of Medicine |
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Key inclusion & exclusion criteria
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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.
Age minimum:
16 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Limbal Stem Cell Deficiency
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Ocular Cicatricial Pemphigoid
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Chemical Burn
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Stevens-johnson Syndrome
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Intervention(s)
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Biological: cultivated oral mucosal epithelial sheet transplantation
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Secondary ID(s)
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MKKim
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COMET trial
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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