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

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ClinicalTrials.gov Identifier: NCT00797056
Recruitment Status : Completed
First Posted : November 25, 2008
Last Update Posted : April 1, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Peripheral Vascular Diseases Drug: G-CSF Drug: Placebo Drug: Aspirin Drug: Clopidogrel Early Phase 1

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of Stem Cell Mobilization by G-CSF to Treat Severe Peripheral Artery Disease (STEMPAD Trial)
Study Start Date : April 2008
Primary Completion Date : April 2012
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: G-CSF Drug: G-CSF
G-CSF 5 mcg/kg/day SQ daily for 10 days
Other Names:
  • Filgrastim
  • Neupogen
Drug: Aspirin
Aspirin 75 mg/day for 14 days
Other Name: acetylsalicylate
Drug: Clopidogrel
Clopidogrel 75mg/day daily for 14 days
Other Name: Plavix
Placebo Comparator: Placebo 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


Outcome Measures

Primary Outcome Measures :
  1. Major limb amputation rate as defined by amputations of the limb that are transmetarsal and higher [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Toe pressure index [ Time Frame: Up to 1 year ]

    Toe brachial index (TBI) and is a calculation based on the systolic blood pressures of the arm and the systolic blood pressures of the toes. The examination is performed with a photoplethysmograph (PPG) infrared light sensor and a very small blood pressure cuff placed around the toe.

    The arm and big toe systolic blood pressure measurements are recorded. Then the big toe systolic pressures are divided by the highest arm pressure to establish an TBI measurement for each leg. A TBI of .75 or greater is consider normal.


  2. Ankle-brachial index [ Time Frame: Up to 1 year ]
    • The Ankle Brachial Index (ABI or ABPI) is the ratio of the blood pressure in the lower legs to the blood pressure in the arms. Compared to the arm, lower blood pressure in the leg is an indication of blocked arteries (peripheral vascular disease or PVD). The ABI is calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressures in the arm.
    • A normal resting ankle-brachial index is 1 or 1.1.

    A resting ankle-brachial index of less than 1 is abnormal. If the ABI is:

    • Less than 0.95, significant narrowing of one or more blood vessels in the legs is indicated.
    • Less than 0.8, pain in the foot, leg, or buttock may occur during exercise (intermittent claudication).
    • Less than 0.4, symptoms may occur when at rest.
    • 0.25 or below, severe limb-threatening peripheral artery disease is probably present.

  3. Ulcer healing as measured by surface area and depth [ Time Frame: Up to 1 year ]
    • Skin ulcerations should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeat measurements. A maximum of 3 ulcers on each lower extremity will be followed.
    • An average of the longest diameter for all ulcerations will be calculated and reported as the baseline average longest diameter. The baseline average will be used as reference by which to characterize the ulcerations.

  4. Improvement in rest pain as measured by the Vascular Quality of Life Questionnaire [ Time Frame: Up to 1 year ]

    -25 questions including questions in activity, symptom, pain, emotional, and social domains.

    Each question has seven choices ranging from "All" to "None"

    • Each domain is scored 1-7=the total of domain item scores divided by the number of questions in the domain.
    • The total score is is also scored 1-7=the total of all the item scores divided by 25.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00797056


Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Patrick Geraghty, M.D. Washington University School of Medicine
More Information

Additional Information:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00797056     History of Changes
Other Study ID Numbers: 07-0043 / 201106083
First Posted: November 25, 2008    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015

Keywords provided by Washington University School of Medicine:
G-CSF
angiogenesis
endothelial progenitor cell
limb ischemia
revascularization

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Aspirin
Clopidogrel
Lenograstim
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents