Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia

PHASE2CompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

June 30, 2014

Study Completion Date

June 30, 2014

Conditions
Arterial Occlusive DiseaseUlcersIschemiaPeripheral 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)

GENETIC

NL003

Day 0: 6mg of NL003 (24 injections of 0.5ml of NL003) and 4ml normal saline(8 injections) Day 14: 6mg of NL003 (24 injections of 0.5ml of NL003) and 4ml normal saline(8 injections) Day 28: 6mg of NL003 (24 injections of 0.5ml of NL003) and 4ml normal saline(8 injections)

GENETIC

NL003

Day 0: 4mg of NL003 (16 injections of 0.5ml of NL003) and 8ml normal saline(16 injections) Day 14: 4mg of NL003 (16 injections of 0.5ml of NL003) and 8ml normal saline(16 injections) Day 28: 4mg of NL003 (16 injections of 0.5ml of NL003) and 8ml normal saline(16 injections)

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 (9)

100032

Peking Union Medical College Hospital, Beijing

100038

Beijing Shijitan Hospital, Beijing

100053

Xuanwu Hospital Capital Medical University, Beijing

100853

The General Hospital of the People's Liberation Army, Beijing

130021

First Hospital of Jilin University, Changchun

210008

Nanjing Drum Tower Hospital, Nanjing

430022

Wuhan Union Hospital, Wuhan

Unknown

The Second Xiangya Hospital of Central South University, Changsha

The Second Hospital of Dalian Medical University, Dalian

All Listed Sponsors
lead

Beijing Northland Biotech. Co., Ltd.

INDUSTRY

NCT01548378 - Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia | Biotech Hunter | Biotech Hunter