机构：[1]Vascular Surgery Department, Xuan Wu Hospital, Capital Medical University, Beijing, China外科系统血管外科首都医科大学宣武医院[2]Vascular Surgery Department, Nanjin Drum Tower Hospital, Nanjing, China[3]Vascular Surgery Department, West China Hospital, Sichuan University, Chengdu, China四川大学华西医院[4]Vascular Surgery Department, The First Affiliated Hospital of Medical School of Zhejiang University, Hangzhou, China浙江大学医学院附属第一医院[5]Vascular Surgery Department, Wuhan Union Hospital, Wuhan, China华中科技大学同济医学院附属协和医院[6]General Surgery Department, The First Affiliated Hospital of Nanchang University, Nanchang, China[7]General Surgery Department, Hebei General Hospital, Shijiazhuang, China[8]General Surgery Department, Baotou Central Hospital, Baotou, China[9]Vascular Surgery Department, The First Bethune Hospital of Jilin University, Changchun, China[10]Vascular Surgery Department, Chinese PLA General Hospital, Beijing, China[11]Vascular Surgery Department, Xiangya Hospital Central South University, Changsha, China[12]Vascular Surgery Department, The First Affiliated Hospital of Chongqin Medical University, Chongqing, China[13]General Surgery Department, Taizhou Hospital of Zhejiang Province, Linhai, China台州恩泽医疗中心(集团)台州医院[14]General Surgery Department, Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University, Shanghai, China[15]School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China[16]Humanwell Healthcare(Group) Co. Ltd, Wuhan, China.[17]Department of Experimental Hematology and Biochemistry, Beijing Institute of Radiation Medicine, Beijing, China
This phase II clinical trial investigated the efficacy and safety of intramuscular injection of plasmid pUDK-HGF which encodes the human hepatocyte growth factor gene in patients with critical limb ischemia (CLI). Resting pain patients (n=119) and patients with leg ulcers (n=121) were enrolled as two cohorts and randomized to receive pUDK-HGF treatment on days 0, 14, and 28. In the resting pain cohort, the proportion of patients with complete pain relief on day 180 after receiving pUDK-HGF injection, as the primary outcome, was significantly higher than that of the placebo group on the same day (p = 0.0148). More responders with >50% pain reduction were also observed in the pUDK-HGF groups than in the placebo groups (p = 0.0168). In the ulcer cohort of patients, pUDK-HGF treatment tended to be superior to the placebo in the percentage of patients with both complete ulcer healing and >50% ulcer healing. No significant differences in the incidence of adverse events or serious adverse events were observed among the groups. The mid dose pUDK-HGF (6 mg) was the most efficacious, and is therefore an appropriate dose for use in a phase III clinical trial. Keywords Peripheral arterial disease, Critical limb ischemia, Gene therapy, Pain at rest, Ulceration, Hepatocyte growth factor, pUDK-HGF treatment, Phase II clinical trial.
基金：
National Science and Technology Major Project, China, No.2014ZX09101-045-002.
语种：
外文
被引次数：
WOS：
PubmedID：
中科院(CAS)分区：
出版当年[2020]版：
大类|2 区医学
小类|2 区生物工程与应用微生物2 区遗传学3 区医学：研究与实验
最新[2023]版：
大类|3 区医学
小类|2 区生物工程与应用微生物3 区遗传学3 区医学：研究与实验
JCR分区：
出版当年[2019]版：
Q1BIOTECHNOLOGY & APPLIED MICROBIOLOGYQ1GENETICS & HEREDITYQ2MEDICINE, RESEARCH & EXPERIMENTAL
最新[2023]版：
Q1GENETICS & HEREDITYQ2BIOTECHNOLOGY & APPLIED MICROBIOLOGYQ2MEDICINE, RESEARCH & EXPERIMENTAL
第一作者机构：[1]Vascular Surgery Department, Xuan Wu Hospital, Capital Medical University, Beijing, China[*1]Vascular Surgery Department of Xuan Wu Hospital, Institute of Vascular Surgery, Capital Medical University, Beijing, 45 Changchun Street, China.
通讯作者：
通讯机构：[*1]Vascular Surgery Department of Xuan Wu Hospital, Institute of Vascular Surgery, Capital Medical University, Beijing, 45 Changchun Street, China.[*2]Beijing Institute of Radiation Medicine, 27 Taiping Road, Beijing, China.
推荐引用方式(GB/T 7714)：
Yongquan Gu,Shijun Cui,Changjian Liu,et al.pUDK-HGF Gene Therapy to Relieve CLI Rest Pain and Ulcer: A Phase II, Double-Blind, Randomized Placebo-Controlled Trial.[J].HUMAN GENE THERAPY.2021,32(15-16):839-849.doi:10.1089/hum.2020.290.
APA：
Yongquan Gu,Shijun Cui,Changjian Liu,Jichun Zhao,Ming Li...&Zuze Wu.(2021).pUDK-HGF Gene Therapy to Relieve CLI Rest Pain and Ulcer: A Phase II, Double-Blind, Randomized Placebo-Controlled Trial..HUMAN GENE THERAPY,32,(15-16)
MLA：
Yongquan Gu,et al."pUDK-HGF Gene Therapy to Relieve CLI Rest Pain and Ulcer: A Phase II, Double-Blind, Randomized Placebo-Controlled Trial.".HUMAN GENE THERAPY 32..15-16(2021):839-849
