Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-2)

PHASE3CompletedINTERVENTIONAL
Enrollment

242

Participants

Timeline

Start Date

August 28, 2019

Primary Completion Date

December 23, 2023

Study Completion Date

December 23, 2023

Conditions
Arterial Occlusive DiseaseIschemiaUlcersPeripheral Vascular Disease
Interventions
GENETIC

NL003

Day 0: 8mg of NL003 (32 injections of 0.5ml of NL003) Day 14: 8mg of NL003 (32 injections of 0.5ml of NL003) Day 28: 8mg of NL003 (32 injections of 0.5ml of NL003)

OTHER

Normal Saline

Day 0: 16ml of Normal Saline (32 injections ) Day 14: 16ml of Normal Saline (32 injections ) Day 28: 16ml of Normal Saline (32 injections )

Trial Locations (21)

100032

Peking Union Medical College Hospital, Beijing

221006

Xuzhou Mining Group General Hospital, Xuzhou

266003

The Affiliated Hospital of Qingdao University, Qingdao

363000

Zhangzhou Municipal Hospital of Fujian Province, Zhangzhou

410000

The Second Xiangya Hospital of Central South University, Changsha

The Third Xiangya Hospital of Central South University, Changsha

710061

First Affiliated Hospital of Xi 'an Jiaotong University, XiAn

Unknown

Second Affiliated Hospital of Chongqing Medical University, Chongqing

Zhongshan Hospital Xiamen University, Xiamen

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

The First Affiliated Hospital of Zhengzhou University, Changchun

Affiliated Hospital of Inner Mongolia Medical University, Baotou

Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan

Qingdao Hiser Hospital Affiliated of Qingdao University(Qingdao Traditional Chinese Medicine Hospital), Qingdao

Fudan University Affiliated Pudong Medical Center, Shanghai

Shanghai 9th People's Hospital Affiliated to Shanghai JiaoTong University, School of Medicine;, Shanghai

The First Affiliated Hospital,Zhejiang University School of Medicine, Hangzhou

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou

zhongshan Hospital Affiliated of Dalian University, Dalian

024000

Chifeng Municipal Hospital, Chifeng

030012

Shanxi Provincial People's Hospital, Taiyuan

All Listed Sponsors
lead

Beijing Northland Biotech. Co., Ltd.

INDUSTRY

NCT04274049 - Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-2) | Biotech Hunter | Biotech Hunter