초록 ▼

○ 1년차 연구에서는 가토와 인간유래 구강점막상피세포 최적 배양 조건을 찾아 생물학적, 기능적, 형태학적 특성을 분석하여 각막상피세포 대체제로의 가능성을 파악하고, 이식 전 세포시트를 분리하는 최적 조건을 확립

○ 2년차 연구에서는 최적 배양조건을 확립하여 표준화 하고 제형화된 세포시트를 이용하여 구강점막상피세포 이식의 최적 이식기법 확립

○ 3년차 연구에서는 세포시트 시작품을 제작하여 안전성을 평가 한 후 유효성 및 생체 안정성 비교 평가하여 최적화된 세포치료술 개발하고, 식약처 승인을 받아 연구자 임상시

○ 1년차 연구에서는 가토와 인간유래 구강점막상피세포 최적 배양 조건을 찾아 생물학적, 기능적, 형태학적 특성을 분석하여 각막상피세포 대체제로의 가능성을 파악하고, 이식 전 세포시트를 분리하는 최적 조건을 확립

○ 2년차 연구에서는 최적 배양조건을 확립하여 표준화 하고 제형화된 세포시트를 이용하여 구강점막상피세포 이식의 최적 이식기법 확립

○ 3년차 연구에서는 세포시트 시작품을 제작하여 안전성을 평가 한 후 유효성 및 생체 안정성 비교 평가하여 최적화된 세포치료술 개발하고, 식약처 승인을 받아 연구자 임상시험 진입

Abstract ▼

Ⅰ. Purpose of study
Cultivated oral mucosal epithelial cell sheet transplantation is effective treatment for intractable total limbal stem cell deficiency, but cell therapy using oral mucosal epithelial cell is wholly lacking in Korea. Developing effective reconstruction therapy using autologous

Ⅰ. Purpose of study
Cultivated oral mucosal epithelial cell sheet transplantation is effective treatment for intractable total limbal stem cell deficiency, but cell therapy using oral mucosal epithelial cell is wholly lacking in Korea. Developing effective reconstruction therapy using autologous stem cell must be settled without delay.

Ⅱ. Contents of study
○ Searching optical culturing condition of autologous oral mucosal epithelial cells in human and rabbit
○ Standardization of optical culturing condition of autologous oral mucosal epithelial cells and developing optimal cell sheet transplantation methods
○ Evaluating safety and efficacy of cultivated oral mucosal epithelial cell sheet transplantation and developing optimal treatment method in limbal stem cell deficiency

Ⅲ. Results of study
○ Securing human oral mucosal epithelial cells and confirming epithelium marker(K1, K3, K4, K13), proliferation marker(Ki-67), and stem cell marker(p63) after cell culture.
○ In cell sheets, confirming epithelium marker(K1, K3, K4, K13), proliferation marker(Ki-67), and stem cell marker(p63)
○ Establishment separation condition of cell sheets on fibrin glue to minimize cellular damage
○ Establishing standardized manufacturing process of cell sheets
○ Comparison of colony forming efficiency, proliferation, migrating activity, cytokine expression, stem cell marker expression, in vivo survival and histological characteristics between cell sheets of Stevens-Johnson syndrome and non Stevens-Johnson syndrome patients
○ Confirmation of stability of mucosal epithelial cell sheet till 24 hours after detachment from the well
○ Increased cell viability in cell sheet after 10uM NecroX5 application for 30 minutes
○ Making prototype of autologous oral mucosal epithelial cell sheet and establishing manufacturing protocol
○ Establishing quality control methods according to advice of KFDA (Korea Food and Drug Administration)
○ Being approved clinical research proposal regarding autologous cultivated oral mucosal epithelial cell sheet transplantation by KFDA

Ⅳ. Utilizing plan of study results
○ Developing effective treatment in intractable total limbal stem cell deficiency patients
○ Activating clinical application of epithelial stem cell therapy
○ Applying optimized autologous cultivated oral mucosal epithelial cell sheet transplantation methods to development of bio-engineered artificial cornea