- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00797056
Stem Cell Mobilization by G-CSF to Treat Severe Peripheral Artery Disease (STEMPAD)
Pilot Study of Stem Cell Mobilization by G-CSF to Treat Severe Peripheral Artery Disease (STEMPAD Trial)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Missouri
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St. Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Aspirin 75 mg/day for 14 days
Other Names:
Clopidogrel 75mg/day daily for 14 days
Other Names:
Saline SQ daily for 10 days
Other Names:
|
Experimental: G-CSF
|
G-CSF 5 mcg/kg/day SQ daily for 10 days
Other Names:
Aspirin 75 mg/day for 14 days
Other Names:
Clopidogrel 75mg/day daily for 14 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Major limb amputation rate as defined by amputations of the limb that are transmetarsal and higher
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Up to 1 year
|
Ankle-brachial index
Time Frame: Up to 1 year
|
A resting ankle-brachial index of less than 1 is abnormal. If the ABI is:
|
Up to 1 year
|
Ulcer healing as measured by surface area and depth
Time Frame: Up to 1 year
|
|
Up to 1 year
|
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"
|
Up to 1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Patrick Geraghty, M.D., Washington University School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Atherosclerosis
- Vascular Diseases
- Peripheral Arterial Disease
- Peripheral Vascular Diseases
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Aspirin
- Clopidogrel
Other Study ID Numbers
- 07-0043 / 201106083
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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