Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-1)

PHASE3CompletedINTERVENTIONAL
Enrollment

302

Participants

Timeline

Start Date

August 2, 2019

Primary Completion Date

June 3, 2024

Study Completion Date

June 3, 2024

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 (13)

100005

Beijing Hospitai, Beijing

100032

Peking Union Medical College Hospital, Beijing

200120

Shanghai seventh people's hospital, Shanghai

221006

Xuzhou Mining Group General Hospital, Xuzhou

266003

The Affiliated Hospital of Qingdao University, Qingdao

363000

Zhangzhou Municipal Hospital of Fujian Province, Zhangzhou

400700

The Ninth People's Hospital of Chongqing, Chongqing

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

Second Affiliated Hospital of Xi 'an Jiaotong University, XiAn

024000

Chifeng Municipal Hospital, Chifeng

030012

Shanxi Provincial People's Hospital, Taiyuan

All Listed Sponsors
lead

Beijing Northland Biotech. Co., Ltd.

INDUSTRY

NCT04275323 - Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-1) | Biotech Hunter | Biotech Hunter