초록 ▼

실제 임상 적용을 위한 사람 코중격 연골세포의 바이오의약품 GMP 생산 공정 확립과 초자연골 특성 유지 및 분화 촉진 조건을 확립하기 위하여 ECM과 가압환경에서의 배양 조건을 확립함. 이를 이식하기 용이하도록 주사제로 만들어, 세포 생존률을 검토함. 또한, 무릎 연골 결손 동물모델을 통한 유효성 평가를 진행하여 초자연골 치료제로서의 효과를 확인하였음. 본 연구과제의 목표인 난치성 질환 극복과 임상 수요 충족의 목표를 충분히 달성하였다고 판단되며, 사회적 문제화되고 있는 유전자치료제의 불명확한 세포 공급원의 단점을 극복할 수 있는

실제 임상 적용을 위한 사람 코중격 연골세포의 바이오의약품 GMP 생산 공정 확립과 초자연골 특성 유지 및 분화 촉진 조건을 확립하기 위하여 ECM과 가압환경에서의 배양 조건을 확립함. 이를 이식하기 용이하도록 주사제로 만들어, 세포 생존률을 검토함. 또한, 무릎 연골 결손 동물모델을 통한 유효성 평가를 진행하여 초자연골 치료제로서의 효과를 확인하였음. 본 연구과제의 목표인 난치성 질환 극복과 임상 수요 충족의 목표를 충분히 달성하였다고 판단되며, 사회적 문제화되고 있는 유전자치료제의 불명확한 세포 공급원의 단점을 극복할 수 있는 효과적인 연골세포치료제로 평가됨. 이는 향후 임상시험과 연계된 심화 연구를 통해 최종 임상 적용을 결과를 달성할 수 있을 것으로 기대함.

(출처 : 요약서 3p)

Abstract ▼

Purpose&Contents
The goal of this suggested research is to develop an innovative hyaline cartilage source of supply (nasal septal cartilage) for reconstruction of patients with the hyaline articular cartilage injury after damage or defect. Also, after using secured autologous or homologous nasal

Purpose&Contents
The goal of this suggested research is to develop an innovative hyaline cartilage source of supply (nasal septal cartilage) for reconstruction of patients with the hyaline articular cartilage injury after damage or defect. Also, after using secured autologous or homologous nasal septal chondrocyte based cell therapy for reconstruction, we aim to proof functionally completed hyaline cartilage regeneration and verify the clinical application. Thus, this therapy could exclude the repetitive invasive procedure of existing cartilage cell therapy from autologous articular chondrocyte donor site, and establish a next-generation cartilage cell therapy to replace previous stem cell therapy that yield uncertain cartilage differentiation.

Results
1. Comparison analysis of the characteristics of nasal septal cartilage and chondrocyte
• Comparison analysis of the histological, biochemical and biomechanical characteristics of nasal septal and articular chondrocyte
• Comparison analysis of the homologous bone marrow derived and the umbilical cord derived mesenchymal stem cell
2. Systematic storage of the human nasal septal chondrocyte and quality management
• Establish a systematic standardized separation, culture and storage
• System establishment of a quality management based on acquisition and storage high-quality human nasal septal chondrocyte
3. The micro-environmental research for maintain large quantity proliferation and differentiation of human nasal septal chondrocyte
• Development of a living body mimic culture environment using measurement of temperature and oxygen partial pressure in human nasal septal cartilage tissue
• Development of a optimized 3-dimensional mimic human nasal septal cartilage cell culture using nano-patterned plate
• Development of a micro/nano surface shape pattern and assessment of cell suitability for regulation of nasal septal chondrocyte fate
• Production of a nasal septal chondrocyte surrounding environment mimic matrix and regulation of a property of matter
4. Secure injectable scaffold for nasal septal chondrocyte
• Function evaluation of injectable scaffold of nasal septal chondrocyte using various hydrogel
• Research micro-environment of surface structure and stiffness that effective in suppression of the mass propagated nasal septal chondrocyte dedifferentiation
• Realization of a dynamic cell culture condition that mimic cartilage tissue environment
• Appraisal of cartilage regeneration ability of the mass propagated nasal septal chondrocyte through a 3-dimensional culture in the culture medium micro-environment.
5. In vivo study of regeneration of cartilage defect
• Evaluation of in vivo transplantation ability after injectable nasal septal chondrocyte transplantation therapy in animal model of cartilage defect
• Non-clinical trial appraisal of GLP certified institution for acquisition of IND approval about pharmacological effect and toxicity and collecting data

Expected Contribution
- Secure a effective culture element original technology, thereby can apply to the different kinds of cells that sensitive to a property of matter (i.e; bone,,muscle, nerve cells)
- A new medical market creation through development of highly improved cartilage cell treatment compared to existing cell therapy
- Be able to expect realization of a cutting-edge medical therapy and creation of a new medical industry, owing to discover a differentiated promising new technology; the human nasal septal chondrocyte cell therapy that substitute existing the health medical technology and product perfectly.
- Make a new era in the intractable articular cartilage diseases treatment through early achievement of definite industrialization and commercialization outcome creation using the human nasal septal chondrocyte cell therapy that very easy to collect and separate.
- It is possible to upgrade hyaline cartilage regeneration treatment using a chondrocyte source that can load-bearing through autologous or homologous transplantation, thereby find grounds that can greatly improvement of domestic health medical technology related articular diseases treatment

(출처 : SUMMARY 5p)

목차 Contents

• 표지 ... 1
• 제 출 문 ... 2
• 보고서 요약서 ... 3
• 국문 요약문 ... 4
• SUMMARY ... 5
• 목차 ... 7
• 1. 연구개발과제의 개요 ... 8
• 1-1. 연구개발 목적 ... 8
• 1-2. 연구개발의 필요성 ... 8
• 1-3. 연구개발 범위 ... 8
• 2. 국내외 기술개발 현황 ... 9
• 3. 연구수행 내용 및 결과 ... 11
• 4. 목표달성도 및 관련분야 기여도 ... 79
• 4-1. 목표달성도 ... 79
• 4-2. 관련분야 기여도 ... 80
• 5. 연구결과의 활용계획 ... 81
• 6. 연구과정에서 수집한 해외과학기술정보 ... 83
• 7. 연구개발성과의 보안등급 ... 109
• 8. 국가과학기술종합정보시스템에 등록한 연구시설·장비 현황 ... 110
• 9. 연구개발과제 수행에 따른 연구실 등의 안전조치 이행실적 ... 111
• 10. 연구개발과제의 대표적 연구실적 ... 112
• 11. 기타사항 ... 113
• 12. 참고문헌 ... 114
• [별첨4] 실적 증빙자료 ... 115
• [별첨5] 기타 첨부서류 ... 163
• 끝페이지 ... 178