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

NCT00797056 | Completed Early Phase 1 DMC

• 1 other identifier: 07-0043 / 201106083
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

G-CSF; angiogenesis; endothelial progenitor cell; limb ischemia; revascularization

Outcome Measures

Primary Outcomes (1)

• Major limb amputation rate as defined by amputations of the limb that are transmetarsal and higher

  1 year

Secondary Outcomes (4)

• Toe pressure index

  Up to 1 year

• Ankle-brachial index

  Up to 1 year

• Ulcer healing as measured by surface area and depth

  Up to 1 year

• Improvement in rest pain as measured by the Vascular Quality of Life Questionnaire

  Up to 1 year

Study Arms (2)

G-CSF

EXPERIMENTAL

Drug: G-CSF; Drug: Aspirin; Drug: Clopidogrel

Placebo

PLACEBO COMPARATOR

Drug: Placebo; Drug: Aspirin; Drug: Clopidogrel

Interventions

G-CSF DRUG

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

Also known as: Filgrastim, Neupogen

G-CSF

Placebo DRUG

Saline SQ daily for 10 days

Also known as: NaCl

Placebo

Aspirin DRUG

Aspirin 75 mg/day for 14 days

Also known as: acetylsalicylate

G-CSF; Placebo

Clopidogrel DRUG

Clopidogrel 75mg/day daily for 14 days

Also known as: Plavix

G-CSF; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have critical limb ischemia secondary to PAD, as defined by the presence of a non-healing ulcer, rest pain, or dry gangrene.
• Patients must have a toe pressure ≤ 30 mm Hg.
• Patients must be ≥18 years old.
• Patient must be able to self-administer a daily subcutaneous injection or have a caregiver who is able to administer a daily subcutaneous injection.
• Patients must be taking or have no absolute contraindication to taking aspirin and clopidogrel. If they are not currently taking aspirin, they must be willing to take aspirin (81 mg daily) and clopidogrel (75 mg daily) for 14 days starting on the first day of G-CSF treatment.
• After being informed of the treatment involved, patients must give written consent. The patient should not have any serious medical or psychiatric illness that would prevent either the giving of informed consent or the receipt of treatment. A built-in period of one week from discussion of the trial and initiation of the trial will be mandatory for enrollment.

You may not qualify if:

• Patients with transmetatarsal or higher amputations in the affected limb are excluded.
• Patients who are candidates for a revascularization procedure.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Peripheral Vascular Diseases

Interventions

Granulocyte Colony-Stimulating Factor; Filgrastim; Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Patrick Geraghty, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 25, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 1, 2015

Record last verified: 2015-03

Locations

US (1)