Stem Cell Mobilization by G-CSF to Treat Severe Peripheral Artery Disease

NCT00797056 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2015-04-01

No results posted yet for this study

Summary

This study is designed to test the use of G-CSF in peripheral vascular disease. The investigators hypothesize that mobilization of angiogenic cells into the blood by granulocyte colony stimulating factor (G-CSF) may stimulate the formation of new blood vessels and result in a sustained improvement in blood flow in patients with severe peripheral arterial disease.

Conditions

  • Peripheral Vascular Diseases

Interventions

DRUG

G-CSF

G-CSF 5 mcg/kg/day SQ daily for 10 days

DRUG

Placebo

Saline SQ daily for 10 days

DRUG

Aspirin

Aspirin 75 mg/day for 14 days

DRUG

Clopidogrel

Clopidogrel 75mg/day daily for 14 days

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Patrick Geraghty, M.D. · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00797056 on ClinicalTrials.gov