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

Sponsored by:	Washington University School of Medicine
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00797056

Purpose

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.

Condition	Intervention	Phase
Peripheral Vascular Diseases	Drug: G-CSF Drug: Placebo Drug: Aspirin Drug: Clopidogrel	Phase III

MedlinePlus related topics: Peripheral Arterial Disease Vascular Diseases

Drug Information available for: Acetylsalicylic acid Clopidogrel Clopidogrel Bisulfate Filgrastim Granulocyte colony-stimulating factor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Pilot Study of Stem Cell Mobilization by G-CSF to Treat Severe Peripheral Artery Disease (STEMPAD Trial)

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

Major limb amputation rate at one year [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toe pressure [ Time Frame: Pre-study and day 1, 10, 30, 90 and 365 ] [ Designated as safety issue: No ]
Ankle-brachial index [ Time Frame: Pre-study and at day 1, 10, 30, 90, and 365 ] [ Designated as safety issue: No ]
Ulcer healing and improvement in rest pain [ Time Frame: Pre-study and at day 1, 10, 30, 90 and 365 ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	April 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
G-CSF: Experimental	Drug: G-CSF G-CSF 5 mcg/kg/day SQ daily for 10 days Drug: Aspirin Aspirin 75 mg/day for 14 days Drug: Clopidogrel Clopidogrel 75mg/day daily for 14 days
Placebo: Placebo Comparator	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

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797056

Contacts

Contact: Eric Choi, M.D.

314-362-6490

choie@wusdosis.wustl.edu

Locations

United States, Missouri
Washington University School of Medicine	Recruiting
St. Louis, Missouri, United States, 63110
Contact: Eric Choi, M.D. 314-362-6490 choie@wusdosis.wustl.edu
Principal Investigator: Eric Choi, M.D.
Sub-Investigator: Daniel C. Link, M.D.
Sub-Investigator: Michael Wilderman, M.D.

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator:

Eric Choi, M.D.

Washington University School of Medicine

More Information

No publications provided

Responsible Party:	Washington University School of Medicine ( Eric Choi, M.D. )
Study ID Numbers:	07-0043
Study First Received:	November 20, 2008
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00797056 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:

G-CSF
angiogenesis
endothelial progenitor cell
limb ischemia
revascularization

Study placed in the following topic categories:

Peripheral Vascular Diseases
Aspirin
Clopidogrel

Vascular Diseases
Platelet Aggregation Inhibitors
Ischemia

Additional relevant MeSH terms:

Peripheral Vascular Diseases
Therapeutic Uses
Clopidogrel
Hematologic Agents

Vascular Diseases
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009