Stevens-johnson Syndrome Clinical Trial
Official title:
An Investigator-initiated Trial (IIT) on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation in Corneal Limbal Deficiency Patients
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.
Status | Available |
Enrollment | 0 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
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. |
N/A
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul | |
Korea, Republic of | Seoul National Unversity Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital | Ministry of Health & Welfare, Korea |
Korea, Republic of,
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. — View Citation
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