摘要
目的分析中国儿科人群干细胞临床研究现状,为国内研究者提供儿科人群干细胞临床研究参考。方法通过检索美国临床试验数据库网站进行我国儿科人群干细胞临床研究登记信息的采集,对临床研究每年新增项目数、临床阶段、适应症、应用干细胞类型、申报者、资金来源、研究设计等方面进行统计分析。结果截至2021-11-30,网站共登记包含儿科人群的干细胞临床研究共89项;我国儿科人群干细胞临床研究在2013年和2019年开展项目数最多,可能与我国近些年陆续出台政策相关;我国儿科人群干细胞临床研究多处于早期探索阶段,以间充质干细胞临床研究为主,研究疾病类型涉及广泛,以血液系统疾病为主;临床研究多由医疗机构发起,以科研探索为主;临床研究类型主要是干预性研究,少数研究设盲,涉及预计样本量例数较少。结论我国儿科人群干细胞临床研究近年来发展平稳,技术仍处于早期发展水平,临床应用前景十分广阔。
Objective To analyze current status of stem cell clinical studies in Chinese pediatric population,and to provide the reference and evidence support for pediatric clinical researchers investigating stem cell in China.Methods Information of stem cell clinical studies in Chinese pediatric population was collected from Clinical Trials.gov website.Mathematical statistics methods were adopted to analyze the status of stem cell clinical studies in Chinese pediatric population from various aspects,included the number of study carried out per year,clinical phase,indications,types of stem cell,sponsors,funding sources and study design.Results As of November 30,2021,the website has registered 89 stem cell clinical studies of pediatric population.In China,stem cell clinical studies of pediatric population had been carried out mostly in 2013 and 2019,which might be related to the stem cell policies of government in the recent years.Stem cell clinical studies are mostly under the early phase of exploration.It mainly focuses on mesenchymal stem cell clinical studies,which apply to wide range of diseases and mainly hematological system.Clinical studies are mostly initiated by medical institutions,which focus on scientific research and exploration.The main types of clinical studies are intervention study.A few studies use the blinded setting,and the estimated sample size is small for most clinical studies.Conclusion The stem cell clinical studies in Chinese pediatric population have been developed steadily in recent years,and the clinical application prospects have been broad.However,the technology is still at the early stage.
作者
王婷谕
梁宇光
王谦
郭春彦
王晓玲
丁倩
WANG Ting-yu;LIANG Yu-guang;WANG Qian;GUO Chun-yan;WANG Xiao-ling;DING Qian(Pharmacy Department,Tianjin Children's Hospital(Tianjin University Children's Hospital),Tianjin 300074,China;Clinical Research Center,National Centerfor Children's Health,China/Beijing Children's Hospital(Bejing),Capital Medical University,Beijing 100045,China)
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2023年第1期122-126,共5页
The Chinese Journal of Clinical Pharmacology
基金
北京市研究型病房示范建设基金资助项目(BCRW202101)。
