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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00797056
First received: November 20, 2008
Last updated: February 12, 2013
Last verified: February 2013

November 20, 2008
February 12, 2013
April 2008
April 2012   (final data collection date for primary outcome measure)
Major limb amputation rate at one year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00797056 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Stem Cell Mobilization by G-CSF to Treat Severe Peripheral Artery Disease
Pilot Study of Stem Cell Mobilization by G-CSF to Treat Severe Peripheral Artery Disease (STEMPAD Trial)

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Peripheral Vascular Diseases
  • Drug: G-CSF
    G-CSF 5 mcg/kg/day SQ daily for 10 days
    Other Names:
    • Filgrastim
    • Neupogen
  • Drug: Placebo
    Saline SQ daily for 10 days
    Other Name: NaCl
  • Drug: Aspirin
    Aspirin 75 mg/day for 14 days
    Other Name: acetylsalicylate
  • Drug: Clopidogrel
    Clopidogrel 75mg/day daily for 14 days
    Other Name: Plavix
  • Experimental: G-CSF
    Interventions:
    • Drug: G-CSF
    • Drug: Aspirin
    • Drug: Clopidogrel
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: Placebo
    • Drug: Aspirin
    • Drug: Clopidogrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
April 2012
April 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00797056
07-0043 / 201106083
Yes
Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Eric Choi, M.D. Washington University School of Medicine
Washington University School of Medicine
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP