Clinical Trial on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation
NCT ID: NCT02149732
Last Updated: 2016-04-20
Study Results
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Basic Information
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AVAILABLE
EXPANDED_ACCESS
2014-05-31
2016-12-31
Brief Summary
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Detailed Description
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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
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Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
16 Years
ALL
No
Sponsors
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Ministry of Health & Welfare, Korea
OTHER_GOV
Seoul National University Hospital
OTHER
Responsible Party
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Principal Investigators
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Mee Kum Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Ophthalmology, Seoul National University College of Medicine
Locations
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Seoul National University Hospital
Seoul, Seoul, South Korea
Seoul National Unversity Hospital
Seoul, Seoul, South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Nishida K, Yamato M, Hayashida Y, Watanabe K, Yamamoto K, Adachi E, Nagai S, Kikuchi A, Maeda N, Watanabe H, Okano T, Tano Y. Corneal reconstruction with tissue-engineered cell sheets composed of autologous oral mucosal epithelium. N Engl J Med. 2004 Sep 16;351(12):1187-96. doi: 10.1056/NEJMoa040455.
Other Identifiers
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MKKim
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
COMET trial
Identifier Type: -
Identifier Source: org_study_id
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