초록 ▼

다공성 구조내에 콜라겐이 담지된 우골 유래 이종이식재의 개발을 목표로 싱가포르 A*STAR와 협력으로 3년간의 연구를 진행 함.
우골을 이용한 이종골의 이식재의 개발을 완료 하였으며, 이에대한 안전성 유효성에 대한 검증결과 동종골과 유사하게 우수성을 확인하였으며, 개발 이식재에 BMP-2와 HS3를 담지하여 골유도능에 대한 안전성과 효능을 시험한 결과 대조군에 비하여 우수한 골 형성을 확인 할수 있어음. 계획된 성과지표에 정량적 자체평과 결과 아주우수함으로 평가 되었기에 성취도 매우 높은 성취도 달성율을 이룬 연구 결고라고 판

다공성 구조내에 콜라겐이 담지된 우골 유래 이종이식재의 개발을 목표로 싱가포르 A*STAR와 협력으로 3년간의 연구를 진행 함.
우골을 이용한 이종골의 이식재의 개발을 완료 하였으며, 이에대한 안전성 유효성에 대한 검증결과 동종골과 유사하게 우수성을 확인하였으며, 개발 이식재에 BMP-2와 HS3를 담지하여 골유도능에 대한 안전성과 효능을 시험한 결과 대조군에 비하여 우수한 골 형성을 확인 할수 있어음. 계획된 성과지표에 정량적 자체평과 결과 아주우수함으로 평가 되었기에 성취도 매우 높은 성취도 달성율을 이룬 연구 결고라고 판단됨

(출처 : 요약서 3p)

Abstract ▼

Purpose&Contents
· The purpose of research is to make great foundation of global market of xenograft through to develop xenograft which has porous structure, and to coat collagen substance into the porous structure for easy perpetration of undifferentiated stem cell in transplantation, and to inc

Purpose&Contents
· The purpose of research is to make great foundation of global market of xenograft through to develop xenograft which has porous structure, and to coat collagen substance into the porous structure for easy perpetration of undifferentiated stem cell in transplantation, and to increase the supply by development of xenograft which has great osteoconductivity and osteoinductivity.

· CELLUMED will realize practical use of the final product after collaborative research and development with institute that has the public’s trust in the Singapore about evaluation of the collagen incorporated xenograft. We have a plan to evaluate the safety and effectiveness of collagen incorporated xenograft until end of 2015.

· Research institute in the Singapore will perform effectiveness evaluation based on international standards. CELLUMED will finish FDA 510(k) submission since 2016 by using the result of research.

· Nowadays, number of patients who suffered by muscular skeletal disease is increasing every years cause by aging population and accident through sports or leisure activities. If there is bone defect cause by these reasons such as the trauma, tumor ablation, osteolysis, etc, bone reconstruction is required using bone graft such as autograft, allograft, synthetic bone graft, xenograft, and so forth for functional restoration, aesthetic, enhancement of heal from bone defect area.

· Autograft is gold standard which has great osteoconductivity and osteoinductivity for transplantation, however additional operation is required for extraction of autograft. Therefore, there are many disadvantage such as complication, delay of recovery period after operation, impossible of enough amount assure, etc.

· Allograft which is most famous bone graft is tend to decrease ability of bone formation during process of immunological rejection, and to be possible infection which derived from donor, and to tend to be different ability of osteoinductive depend on samples. In the case of synthetic bone, it can be only role of scaffold to keep inside area on defected area, not possible to replace patient’s bone, and it has no osteoinductive.

· Therefore, development of suitable bonegraft is urgently needed, and it must be hurry on development of ideal bonegraft which can be replaced autograft.

Results
· The key point of this research is to make strong osteoinductive for differentiation of new bone formation, and to maintain osteoconductive structure which has porosity from chemical treated bovine bone.

· In addition, we try to seek the condition of improvement of osteoinductive through that, not only the collagen in pours structure but also to investigate about recombinant bone morphogenic protein (rhBMP).

· We try to secure incrementality performance of xenograft through chemical treatment of xenograft which is biological non active material, and safety of use to minimize disease transmission and immunorejection.

Expected Contribution
· The xenograft alternative material by this development is to use patients who have damage on bone, ligament, tendon, and so forth directly for cure during operation.

· The developed product treated surface coating with collagen or rhBMP in the porous structure to increase osteoinductivity.

· It is applicability to develop tissue restoration medical device which is derived from animal.

· It can be improved the income structure of stockbreeding farmhouse which has suffering by FTA, or pressure of agricultural products import opening.

(출처 : SUMMARY 5p)

목차 Contents

• 표지 ... 1
• 제출문 ... 2
• 보고서 요약서 ... 3
• 국문 요약문 ... 4
• SUMMARY ... 5
• 목차 ... 6
• 1. 연구개발과제의 개요 ... 7
• 1. 연구개발 목적 ... 7
• 2. 연구개발의 필요성 ... 7
• 3. 연구개발 범위 ... 8
• 2. 국내외 기술개발 현황 ... 9
• 1. 국내에서 출시된 골 이식재관련 제품 ... 9
• 2. 국외에서 출시된 골 이식재관련 제품 ... 9
• 3. 국내 시장 동향 ... 11
• 4. 국외 시장 동향 ... 12
• 3. 연구수행 내용 및 결과 ... 13
• 1. 기술개발 목표 ... 13
• 2. 연차별 세부계획 ... 14
• 4. 목표달성도 및 관련분야 기여도 ... 87
• 4-1. 목표달성도 ... 87
• 4-2. 관련분야 기여도 ... 87
• 5. 연구결과의 활용계획 ... 89
• 6. 연구과정에서 수집한 해외과학기술정보 ... 91
• 7. 연구개발성과의 보안등급 ... 92
• 8. 국가과학기술종합정보시스템에 등록한 연구시설·장비 현황 ... 92
• 9. 연구개발과제 수행에 따른 연구실 등의 안전조치 이행실적 ... 93
• 10. 연구개발과제의 대표적 연구실적 ... 99
• 11. 기타사항 ... 99
• 12. 참고문헌 ... 100
• 별첨: 실적 증빙자료 ... 103
• 별첨: FINAL PROGRESS REPORT 국문 요약서 ... 111
• 첨부문서 ... 115
• 끝페이지 ... 194