Abstract ▼

□ Purpose&Contents
■ Osteoporotic vertebral compression fractures (OVCFs) lead to morbidity and mortality. Therefore, it is very important to prevent and treat osteoporotic fractures.
■ The aim of this study was to verify the safety and efficacy of umbilical cord wharton’s jelly-derived mesenc

□ Purpose&Contents
■ Osteoporotic vertebral compression fractures (OVCFs) lead to morbidity and mortality. Therefore, it is very important to prevent and treat osteoporotic fractures.
■ The aim of this study was to verify the safety and efficacy of umbilical cord wharton’s jelly-derived mesenchymal stem cells (WJ-MSCs) and parathyroid hormone (PTH) combination therapy in patients with OVCFs and obtain IND approval for subsequent phase II clinical trials.
■ Research Content
● Production and quality control of WJ-MSCs therapy
● Recruitment and Selection of Subjects
● Conduct clinical trials after establishing control and test groups Control group (10 patients): PTH daily subcutaneous injection for 24 weeks after clinical initiation
Test group (10):
Direct transplantation of cell therapy to OVCFs
Intravenous cell therapy 1 week later concurrently PTH daily subcutaneous injection for 24 weeks after clinical initiation
● Evaluation of safety and efficacy for 12 months after clinical initiation
● Preparing and obtaining IND approval for subsequent clinical trials

□ Results
■ As of plan, Phase 1 clinical trial of WJ-MSCs and PTH in patients with OVCFs was completed.
■ Clinical Trial Results Confirm the safety and efficacy of the investigational drug.
■ Based on the results of the clinical trials, data for IND approval has been submitted to the MFDS for approval of the upper level clinical trial plan.

□ Expected Contribution
■ We are conducting a follow-up high-level clinical trial, completing a high-level clinical trial in 2023, and planning to apply for item approval or technology transfer in 2023.
■ Providing the foundation technology for developing cell therapies in other diseases by developing successful OVCFs stem cell cell therapy
■ Creation of stem cell therapy market for OVCFs
■ Developing effective OVCFs stem cell therapy to improve the quality of life of patients and reduce social and economic costs caused by diseases
■ Fundamentally treat OVCFs to relieve surgical treatment and to reduce side effects and medical costs

(출처 : SUMMARY 5p)

목차 Contents

• 표지 ... 1
• 제출문 ... 2
• 보고서 요약서 ... 3
• 국문 요약문 ... 4
• SUMMARY ... 5
• Table of Contents ... 6
• 목차 ... 7
• 1. 연구개발과제의 개요 ... 8
• 1-1. 연구개발 목적 ... 8
• 1-2. 연구개발의 필요성 ... 8
• 1-3. 연구개발 범위 ... 9
• 2. 국내외 기술개발 현황 ... 10
• 3. 연구수행 내용 및 결과 ... 13
• 3-1. 연구 수행내용 ... 14
• 3-2. 임상시험 결과 ... 22
• 3-3. 종합평가 ... 29
• 4. 목표달성도 및 관련분야 기여도 ... 30
• 4-1. 목표달성도 ... 30
• 4-2. 관련분야 기여도 ... 30
• 5. 연구결과의 활용계획 ... 30
• 6. 연구과정에서 수집한 해외과학기술정보 ... 31
• 7. 연구개발성과의 보안등급 ... 31
• 8. 국가과학기술종합정보시스템에 등록한 연구시설·장비 현황 ... 32
• 9. 연구개발과제 수행에 따른 연구실 등의 안전조치 이행실적 ... 32
• 10. 연구개발과제의 대표적 연구실적 ... 34
• 11. 기타사항 ... 35
• 12. 참고문헌 ... 36
• 별첨4. 실적 증빙자료 ... 37
• 끝페이지 ... 42