KoNIBP 재단법인 국가생명윤리정책원 (KOREA NATIONAL INSTITUTE FOR BIOETHICS POLLICY)

Guidelines for Stem cell science and Clinical translation

줄기세포연구 및 임상중개에 관한 지침

ISSCR(INTERNATIONAL SOCIETY FOR STEM CELL RESEARCH)

- 가이드라인 바로가기 : http://www.isscr.org/docs/default-source/guidelines/isscr-guidelines-for-stem-cell-science-and-clinical-translation.pdf?sfvrsn=2

- 첨부파일 : 하단에 첨부를 눌러주세요   2016_isscr-guidelines-for-stem-cell-science-and-clinical-translation.pdf

- 참고 : http://www.nibp.kr/xe/news2/62699

TABLE OF CONTENTS

Preface.......................................................................................................2
Dedication.................................................................................................2
1. Fundamental Ethical Principles..........................................................4
2. Laborator y-based Human Embr yonic Stem Cell Research,
Embr yo Research, and Related Research Activities......................5
2.1 Review Processes..........................................................................................................5
2.2 Procurement of Biomaterials......................................................................................8
2.3 Derivation, Banking and Distribution of
Human Pluripotent Stem Cell Lines....................................................................... 11
2.4 Mechanisms for Enforcement.................................................................................. 12
3. Clinical Translation of Stem Cells.................................................. 13
3.1 Cell Processing and Manufacture............................................................................ 13
3.1.1 Sourcing Material............................................................................................................ 14
3.1.2 Manufacture..................................................................................................................... 14
3.2 Preclinical Studies ..................................................................................................... 15
3.2.1 General Considerations................................................................................................. 16
3.2.2 Safety Studies.................................................................................................................. 16
3.2.3 Efficacy Studies .............................................................................................................. 18
3.2.4 Transparency and Publication....................................................................................... 18
3.3 Clinical Research........................................................................................................ 19
3.3.1 Over sight.......................................................................................................................... 19
3.3.2 Standards for Clinical Research Conduct.................................................................. 20
3.3.3 Issues Par ticular to Ear ly Phase Trials......................................................................... 22
3.3.4 Issues Par ticular to Late Phase Trials.......................................................................... 23
3.3.5 Research Subject Follow-up and Trial Monitoring .................................................. 23
3.3.7 Transparency and Repor ting of Research Results.................................................... 24
3.4 Stem Cell-based Medical Innovation...................................................................... 24
3.5 Clinical Application.................................................................................................... 26
3.5.1 Regulator y Approval...................................................................................................... 26
3.5.2 Access and Economics................................................................................................... 27
4. Communications............................................................................... 28
5. Standards in Stem Cell Research................................................... 29
Acknowledgements............................................................................... 30
ISSCR Guidelines Updates Task Force.............................................. 30
Appendices.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Glossar y.................................................................................................. 32
References.............................................................................................. 35