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Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia

NCT01548378 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-01-22

No results posted yet for this study

Summary

The purpose of this study is to evaluate whether intramuscular injections of NL003 into the calf is safe and effective in the treatment of critical limb ischemia

Conditions

  • Arterial Occlusive Disease
  • Ulcers
  • Ischemia
  • Peripheral 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 )

Sponsors & Collaborators

  • Beijing Northland Biotech. Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01548378 on ClinicalTrials.gov