Ocular Surface Reconstruction With Cultivated Autologus Mucosal Epithelial Transplantation
This trial is active, not recruiting.
|Condition||ocular surface disease|
|Treatment||cultivated mucosal epithelial transplantation|
|Phase||phase 2/phase 3|
|Start date||January 2008|
|End date||June 2013|
|Trial size||20 participants|
|Trial identifier||NCT01942421, 639/2551(EC2)|
The purpose of this study is to elucidate the appropriate condition of developing cultivated autologous oral mucosal epithelial graft and evaluate the surgical outcome of transplantation of the cultivated cells in the patients.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Cultivated mucosal epithelial transplantaion to limbal deficiency patients
Ocular surface clinical and pathological status(signs of limbal deficiency and immunopathological markers)after the surgery
time frame: Three years
Male or female participants at least 18 years old.
Inclusion Criteria: - Bilateral limbal stem cell deficiency proved by specific clinical features and impression cytology Exclusion Criteria: - Age under 18 - Active ocular infection, Severe dry eye, Uncontrolled glaucoma - Immunocompromised host - Pregnancy
|Official title||Ocular Surface Reconstruction With Cultivated Autologus Mucosal Epithelial Transplantation.|
|Principal investigator||Pinnita Prabhasawat, MD|
|Description||Ocular surface damage caused by severe ocular surface diseases. Corneal limbal stem cell transplantation has been demonstrated to improve the outcome of ocular surface reconstruction. However, the conventional management of allograft limbal transplantation generally has unsatisfactory outcome because of high risk of rejection and requires long-life immunosuppressive medications. Ocular surface reconstruction with cultivated autologous mucosal epithelial transplantation is served to improve the surgical results of ocular surface reconstruction and decrease the use of immunosuppressive medications|
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