국내·외 첨단재생의료 문헌 분석

Analysis of Advanced Regenerative Medicine Literature: Focusing on Researcher-Led and Pharmaceutical Company-Led Clinical Research

OBJECTIVES The purpose of this study is to understand the status of clinical research in advanced regenerative medicine, and to analyze each detailed item with a focus on researcher-led and pharmaceutical company -led clinical research. METHODS Among the documents registered in PubMed from 1 January 2018 to 29 June 2021, the clinical research literature was selected as the literature that corresponds to the advanced regenerative medicine clinical research and contains adverse reaction information. Publication year, country, indication type, and follow-up period were selected as variables to analyze clinical research literature by research funding. RESULTS As a result of the study, 220 eligible studies were identified through a literature search. 163 cases (74%) of researcher-led clinical research and 57 cases (26%) of pharmaceutical company -led clinical research were investigated. In the case of advanced regenerative medicine indications, researcher-led clinical research conducted overwhelmingly in clinical studies of brain/neuro/psychiatric diseases and eye diseases. As a result of analyzing the adverse events described in the entire clinical research literature, in the order of headache, nausea, fatigue, fever, and anemia were observed in pharmaceutical company-led clinical research and fatigue, prexia, headache, and hypertension in researcherled clinical research. CONCLUSIONS We expect this study will maximize the efficiency of clinical research information utilization and will help concentrate on building a safety management system.