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

2014-08-27 03:26:02 | BioPortfolio


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.


One fourth of patients with peripheral artery disease (PAD) of the lower extremities have severe symptomatic disease and 1-2% have critical limb ischemia (CLI). In patients with CLI, the risk of limb amputation at 1 year is 50%. In addition, patients with CLI often have rest pain, non-healing ulcers and severe limitations of ambulation. Revascularization procedures, including bypass surgery, percutaneous transluminal angioplasty and angioplasty with stenting, are currently the only treatment options. However, many patients are not eligible for a revascularization procedure due to small vessel disease or coexisting medical problems. Moreover, restenosis rates are high.

There is currently no effective non-invasive treatment for critical limb ischemia. We hypothesize that mobilization of angiogenic cells into the blood by granulocyte colony stimulating factor (G-CSF) may stimulate angiogenesis in areas of ischemia and result in a sustained improvement in blood flow in patients with severe PAD.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Peripheral Vascular Diseases


G-CSF, Placebo, Aspirin, Clopidogrel


Washington University School of Medicine
St. Louis
United States




Washington University School of Medicine

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:26:02-0400

Clinical Trials [2830 Associated Clinical Trials listed on BioPortfolio]

Mirror Trial - Follow-Up Management of Peripheral Arterial Intervention With Clopidogrel

The Mirror Study is a randomized, double-blinded mono-centre trial the access the periinterventinal and postinterventional administration of clopidogrel in patients with peripheral vascula...

COMbination of Clopidogrel and Aspirin for Prevention of Early REcurrence in Acute Atherothrombotic Stroke

Primary objective: - Comparison of efficacy of the combination therapy (clopidogrel plus aspirin) and the aspirin alone (main comparison) to prevent any recurrent ischemic lesion ...

Clopidogrel/Aspirin Interaction Study

This study will explore the effect of different doses of aspirin on the effects of double-dose or standard dose clopidogrel.

Perioperative Aspirin Response in Patients Undergoing Vascular Surgery

Reduced antiplatelet activity (low response (LR)/high on-treatment platelet reactivity (HPR)) of aspirin (ALR) or clopidogrel (CLR) is associated with an increased risk of thromboembolic e...

Edoxaban in Peripheral Arterial Disease

This study is a randomized, open-label, blinded endpoint, parallel-group, active-control, multi-center, proof-of-concept study in subjects with Peripheral Arterial Disease (PAD), designed ...

PubMed Articles [14045 Associated PubMed Articles listed on BioPortfolio]

Aspirin better than clopidogrel on major adverse cardiovascular events reduction after ischemic stroke: A retrospective nationwide cohort study.

Several clinical trials reported that clopidogrel was superior to aspirin in secondary stroke prevention by reducing the risk of major adverse cardiovascular events (MACE). We aimed to compare the eff...

Direct Oral Anticoagulants and Coronary Artery Disease: The Debacle of Aspirin Era?

Longstanding aspirin is the cornerstone to prevent recurrence of thrombotic events in patients with ischemic heart disease. However, clopidogrel, a more potent antiplatelet agent, is preferred over as...

Efficacy and safety of combination of tadalafil and aspirin versus tadalafil or aspirin alone in patients with vascular erectile dysfunction: a comparative randomized prospective study.

We aimed to investigate the efficacy and safety of tadalafil, aspirin, and tadalafil + aspirin combination therapy in vascular erectile dysfunction (VED).

Risk of Hypoglycemia and Concomitant Use of Repaglinide and Clopidogrel:A Population-Based Nested Case-Control Study.

This nested case-control study evaluated the potential interaction between repaglinide and clopidogrel. Cases were defined by inpatient admissions or emergency room visits due to hypoglycemia. Concomi...

Effects of Edoxaban on the Cellular and Protein Phase of Coagulation in Patients with Coronary Artery Disease on Dual Antiplatelet Therapy with Aspirin and Clopidogrel: Results of the EDOX-APT Study.

In patients requiring dual antiplatelet therapy (DAPT) who also have an indication to be treated with oral anticoagulant (OAC) drugs, aspirin withdrawal reduces the risk of bleeding. There is limited ...

Medical and Biotech [MESH] Definitions

Obstruction of the flow in the SPLANCHNIC CIRCULATION by ATHEROSCLEROSIS; EMBOLISM; THROMBOSIS; STENOSIS; TRAUMA; and compression or intrinsic pressure from adjacent tumors. Rare causes are drugs, intestinal parasites, and vascular immunoinflammatory diseases such as PERIARTERITIS NODOSA and THROMBOANGIITIS OBLITERANS. (From Juergens et al., Peripheral Vascular Diseases, 5th ed, pp295-6)

Pathological processes involving any of the BLOOD VESSELS in the cardiac or peripheral circulation. They include diseases of ARTERIES; VEINS; and rest of the vasculature system in the body.

A non-steroidal anti-inflammatory agent that is less effective than equal doses of ASPIRIN in relieving pain and reducing fever. However, individuals who are hypersensitive to ASPIRIN may tolerate sodium salicylate. In general, this salicylate produces the same adverse reactions as ASPIRIN, but there is less occult gastrointestinal bleeding. (From AMA Drug Evaluations Annual, 1992, p120)

Asthmatic adverse reaction (e.g., BRONCHOCONSTRICTION) to conventional NSAIDS including aspirin use.

Pathological processes involving any one of the BLOOD VESSELS in the vasculature outside the HEART.

More From BioPortfolio on "Stem Cell Mobilization by G-CSF to Treat Severe Peripheral Artery Disease"

Quick Search

Relevant Topics

Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells.  In vertebrates, it is composed of blo...

Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...

Searches Linking to this Trial