Regulatory aspects of xenotransplantation in Korea
- 주제(키워드) clinical trial , Korean regulation , xenotransplantation
- 주제(기타) Medicine, Research & Experimental
- 주제(기타) Transplantation
- 설명문(일반) [Kwon, Ivo] Ewha Womans Univ, Dept Med Educ, Coll Med, Seoul, South Korea; [Kwon, Ivo; Park, Chung-Gyu] Seoul Natl Univ, Coll Med, Xenotransplantat Res Ctr, Seoul, South Korea; [Park, Chung-Gyu] Seoul Natl Univ, Dept Microbiol & Immunol, Coll Med, Seoul, South Korea; [Park, Chung-Gyu] Seoul Natl Univ, Canc Res Inst, Coll Med, Seoul, South Korea; [Park, Chung-Gyu] Seoul Natl Univ, Inst Endem Dis, Coll Med, Seoul, South Korea; [Park, Chung-Gyu] Seoul Natl Univ, Dept Biomed Sci, Grad Sch, Seoul, South Korea; [Park, Chung-Gyu] Seoul Natl Univ Hosp, Biomed Res Inst, Seoul, South Korea; [Lee, SeungHwan] Seoul Natl Univ Hosp, Clin Trials Ctr, Seoul, South Korea; [Lee, SeungHwan] Seoul Natl Univ Hosp, Dept Clin Pharmacol & Therapeut, Seoul, South Korea
- 등재 SCIE, SCOPUS
- 발행기관 WILEY
- 발행년도 2020
- 총서유형 Journal
- URI http://www.dcollection.net/handler/ewha/000000174963
- 본문언어 영어
- Published As http://dx.doi.org/10.1111/xen.12602
- PubMed https://pubmed.ncbi.nlm.nih.gov/32420655
초록/요약
Background The xenotransplant clinical trial with human subjects seems to be technically feasible, however, it needs the strict regulatory framework from the domestic as well as the international level to make sure the safety of the human subject and the general public. Methods The authors reviewed and introduced the current regulations regarding the xenotransplant clinical trial in Korea focusing on the recently stipulated act (Advanced Regenerative Medicine and Biopharmacology Act, ARMBA) and the role of the related government agencies and health institutions. Results and Conclusion Korea is ready to conduct the xenotransplant clinical trial with human subjects in the current regulatory framework satisfying the requirements of the international guidance. The responsible governmental agencies would collaborate in control the xenotransplant clinical trial under the ARMBA and other related acts and guidance.
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