초록

제대혈 유래 줄기세포 치료제로 기존의 치료제로는 제약이 있는 중증 아토피피부염 환자의 ‘Medical Ummet Needs’를 해소하기 위하여 본 연구과제를 통하여 기전연구, 효능 분석 및 상업화 임상 2b 상 완료 후 상업화 임상 3상 승인 및 진행을 통한 아토피 피부염 환자의 치료를 위한 줄기세포치료제 개발을 목표로 함.

(출처 : 보고서 요약서 3p)

Abstract ▼

Purpose&Contents
○ Development of stem cells for the treatment of patients with atopic dermatitis through progress of commercialized clinical phase 2b studies.

○ Acquisition of Efficacy and safety data through 2b phase clinical trial and commercialized phase III clinical IND approval.
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Purpose&Contents
○ Development of stem cells for the treatment of patients with atopic dermatitis through progress of commercialized clinical phase 2b studies.

○ Acquisition of Efficacy and safety data through 2b phase clinical trial and commercialized phase III clinical IND approval.

○ Comparison of existing treatments for atopic dermatitis and new drugs that have recently proven efficacy and cell treatments

- Analysis of efficacy of treatements for atopic dermatitis
- Establishment of analysis studies for new mechanism
- Identification and analysis of new stem cell mechanism
- Verification of new mechanism of action

Results
○ Completion of commercialized 2b phase clinical trial and commercialized phase III clinical IND approval.
- According to the recommendation of the Food and Drug Administration and the Central Pharmaceutical Affairs Review Committee, approved plan changed for phase 3 clinical trial. Phase 2b clinical trials were conducted for 0 patients.

- Completion of assay for content or potency according to recommendation for approval of phase III clinical trial IND

- Completion of overcharge test according to recommendation of pharmacy for approval of Phase III clinical trial IND

○ A new mechanism development of therapeutic efficacy for severe atopic dermatitis
- Establishment of B lymphocyte and cell-derived mediators analysis method:
Establishment of B lymphocyte isolation, maturation, proliferation method

- Establishment of analysis method for T lymphocytes and cell-derived mediators: T lymphocyte isolation and help T cell proliferation and differentiation to each lineage.

- Establishment of analysis method for skin cells and cell-derived mediators:
Establishment of culture method HeCaT cell line which is keratin cell line in human skin

Expected Contribution
○ Phase 3 clinical trial
- Based on the results of Phase 2b clinical trials conducted through this project, we conducted clinical trials of Phase 3 clinical trials to confirm the safety and efficacy of cell therapy for treating patients with severe atopic dermatitis.

○ Approval of NDA and market entry
- After completing phase 2b and phase 3 clinical trials, the company enters into the market after the approval of NDA and will establish a sales network for the development of stem cell therapies with Big Parma

○ Expansion of target patients
- Patients with severe atopic dermatitis will first enter the market. After performing additional clinical trials to expand the target patients, patients with moderate to severe disease will be treated.

- Patients with moderate to severe pediatric adolescents will be given additional clinical trials to further

○ Development of other diseases medicines
- Results from studies can contribute greatly to the establishment of molecular immunological basis for the basic research fields of other diseases related to allergies. The results of clinical trials obtained through this study can be applied to the development of other disease medicines using stem cells.

(출처 : SUMMARY 5p)

목차 Contents

• 표지 ... 1
• 제 출 문 ... 2
• 보고서 요약서 ... 3
• 국문 요약문 ... 4
• SUMMARY ... 5
• Contents ... 7
• 목차 ... 8
• 1. 연구개발과제의 개요 ... 9
• 2. 국내외 기술개발 현황 ... 11
• 3. 연구수행 내용 및 결과 ... 17
• 4. 목표달성도 및 관련분야 기여도 ... 20
• 4-1. 목표달성도 ... 20
• 4-2. 관련분야 기여도 ... 20
• 5. 연구결과의 활용계획 ... 21
• 6. 연구과정에서 수집한 해외과학기술정보 ... 23
• 7. 연구개발성과의 보안등급 ... 23
• 8. 국가과학기술종합정보시스템에 등록한 연구시설·장비현황 ... 23
• 9. 연구개발과제 수행에 따른 연구실 등의 안전조치 이행실적 ... 24
• 10. 연구개발과제의 대표적 연구실적 ... 24
• 11. 기타사항 ... 24
• 12. 참고문헌 ... 25
• 끝페이지 ... 26