초록 ▼

1. 1단계 연구내용
- 전임상 및 임상용 자기유래 뼈세포치료제 제조 기술 및 시설 확립
- 뼈세포치료제 기준 및 시험방법 자료 완성
- 뼈세포치료제 전임상 프로토콜 확립 및 전임상 효능, 용법용량 평가완료
- 뼈세포치료제 전임상 독성 평가 완료
2. 2단계 연구내용
- 뼈세포치료제 안전성 유효성관련 전임상 자료완성
- 뼈세포치료제 임상시험 프로토콜 확립
- 뼈세포치료제 임상시험 진입 및 시험
- 기준 및 시험방법 및 안전성 유효성 평가 심사
- 자기유래 뼈세포치료제 임상시험 완

1. 1단계 연구내용
- 전임상 및 임상용 자기유래 뼈세포치료제 제조 기술 및 시설 확립
- 뼈세포치료제 기준 및 시험방법 자료 완성
- 뼈세포치료제 전임상 프로토콜 확립 및 전임상 효능, 용법용량 평가완료
- 뼈세포치료제 전임상 독성 평가 완료
2. 2단계 연구내용
- 뼈세포치료제 안전성 유효성관련 전임상 자료완성
- 뼈세포치료제 임상시험 프로토콜 확립
- 뼈세포치료제 임상시험 진입 및 시험
- 기준 및 시험방법 및 안전성 유효성 평가 심사
- 자기유래 뼈세포치료제 임상시험 완성

Abstract ▼

I. Purpose and necessity of study
1. Purpose : Preclinical and clinical study of autologous bone-forming cell therapy Product which is manufactured for biological regeneration about nonunion bone fracture and AVN.
2. Necessity : Increase of medical expenses about whole body bone loss with gray

I. Purpose and necessity of study
1. Purpose : Preclinical and clinical study of autologous bone-forming cell therapy Product which is manufactured for biological regeneration about nonunion bone fracture and AVN.
2. Necessity : Increase of medical expenses about whole body bone loss with graying of people, promote effective treatment using bone-ceil therapy product in whole body bone loss healing market, national wealth accumulation through prior occupation of the world market
II. Contents and scope of study
1. Establishment of technique and instrument of manufacturing autologous bone-forming cell therapy for preclinical and clinical study
2. Completion of preclinical trial to autologous bone-forming cell therapy product
3. Completion of clinical trial to autologous bone-forming cell therapy product
4. Admission to product approval of autologous bone-forming cell therapy product
III. Results of study
1. Manufacturing and quality control of autologous bone-forming cell therapy product
a. Establishment of manufacturing and quality control facilities of autologous bone-forming cell therapy for preclinical and clinical study
b. Establishment of manufacturing method and quality control of bone-forming cell therapy product
2. Preclinical trial of autologous bone-forming cell therapy product
a. Completion of protocol in preclinical trial
b. Completion of GLP toxicity test in preclinical trial
c. Completion of efficiency test in preclinical trial
d. Completion of usage and dosage in preclinical trial
e. Completion of follow up test of cell survival
f. Completion of tumor formation test
3. Stability test of autologous bone-forming cell therapy product
a. Completion of long term preservation test
b Completion of stress and accelerate life test
4. Clinical study of autologous bone-forming cell therapy product

a. Establishment of protocol in clinical trial
b. Approval clinical trial
c. Completion of phase 3 clinical trial to safety and efficacy evaluation of ostem (autologous bone-forming cell) for two months in patient of bone fracture.
d. Completion of research clinical trial for short term safety and availability valuation of OSTEM (autologous bone-forming cell) for one week and efficacy observation for six months in patients with osteonecrosis
5. Establishment of identity, purity, potency test method of autologous bone-forming cell therapy product.
6. Admission to product approval of autologous bone-forming cell therapy product
a. Request the examination of standard and test method
b. Request the examination of efficacy and safety test
IV. Utilizing scheme of study results
1. Pathfinding way of cell therapy technology and merchandise export including bone forming-cell therapy product.
2. Medical CE (Communaut` Europeen) certification was acquired by the kits which composed the disposable product require to manufacture bone-cell therapy product, and it can supply the total solution to the world with GMP facility and cell therapy product manufacturing technology.
3. Development of various medical supplies and devices apply to musculoskeletal system disorder

목차 Contents

• II. 총괄연구과제 연구결과...34
• 1. 연구개발과제의 배경 및 필요성...35
• 2. 국내외 기술개발 현황...40
• 3. 연구개발과제의 추진체계...43
• 4. 연구개발수행 내용 및 결과...44
• 5. 목표달성도 및 관련분야 기여도...117
• 6. 향후 연구성과 추진계획...119
• 7. 연구개발결과의 파급효과...120
• 8. 연구개발결과의 활용계획...122
• 9. 연구개발과정에서 수집한 해외과학기술정보...126
• 10. 참고문헌...128
• III. 첨부서류...130
• 1. 자체평가의견서...132
• 2. 실적 증빙자료...138
• 3. 기타 첨부서류...196
• 양식 3. 최종보고서 비공개 승인요청...198