Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) and Mobilization of Progenitor Cells in Peripheral Arterial Disease
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - 80 |
| Updated: | 11/23/2013 |
| Start Date: | September 2009 |
| End Date: | December 2013 |
| Contact: | Joseph C Poole, MD PhD |
| Email: | jcpoole@emory.edu |
| Phone: | 404-712-9186 |
Granulocyte-Macrophage Stimulating Factor (GM-CSF) and Mobilization of Progenitor Cells in Peripheral Arterial Disease: A Phase II Randomized Study
Peripheral arterial disease is a common condition in older adults involving poor arterial
circulation in the legs leading to leg pain and debility. The body's own circulating blood
vessel stem cells may help to improve circulation. This study will test whether treatment
with the drug granulocyte macrophage colony stimulating factor (GM-CSF) will improve
symptoms and signs of peripheral arterial disease over placebo after four weeks of therapy.
As well this study will examine whether improvements in blood vessel function can be
observed. Finally, we will measure blood vessel function and stem cell levels in order to
determine whether they can help to predict whether patients wither peripheral arterial
disease will suffer further cardiovascular complications.
Inclusion Criteria:
- 160 males or post-menopausal females between 21 and 80 years of age. Female subjects
must be (a) post-menopausal, (b) surgically sterile or (c) use adequate birth control
and have a negative pregnancy test within 3 days prior to administration of study
drug and should not be breastfeeding.
- Documented PAD (By Ankle-Brachial Indices or Angiographically)
- Clinically stable (at least 2 months) history of intermittent claudication with no
change in symptom severity in the 2 months prior to screening.
- On stable statin therapy for previous 3 months.
- Peak Walking Time (PWT) between 1 and 12 minutes on a standardized Gardner treadmill
protocol.
- A Doppler-derived ankle-brachial index (ABI) of < 0.85 in the symptomatic limb after
10 minutes of rest at screening. For subjects with an ABI of >1.3 (non-compressible
arteries) a Toe-Brachial Index (TBI) of < 0.70 must be obtained for subject
qualification, or if ABI is > 0.85 to 1.0 , and a reduction of 20% in ABI measured
within 1 minute of treadmill testing.
- On appropriate and stable medical therapy for atherosclerosis for at least 2 months.
- Able to give informed consent.
- Diabetics with a dilated eye exam excluding proliferative retinopathy in the previous
12 months.
Exclusion Criteria:
- Recent or current active infections (treated with antibiotics).
- Recent (3 months) change in statin therapy
- Critical limb ischemia either chronic (category 3 and 4 of SVS classification) or
acute ischemia manifested by rest pain, ulceration, or gangrene.
- Lower extremity vascular surgery, angioplasty or lumbar sympathectomy within 3 months
of enrollment.
- Participation in a structured exercise treatment protocol within 3 months of
enrollment.
- Prior myeloid cancer.
- Unstable angina, myocardial infarction, TIA, stroke or revascularization in the
preceding 4 months.
- Severe heart failure (Class III or IV), heart muscle disease or atrial fibrillation.
- Limitation on exercise for symptoms other than intermittent claudication such as
arthritis or dyspnea.
- Uncontrolled diabetes mellitus (defined as HbA1c > 10.0).
- Chronic renal disease (creatinine of >2.5 mg/dl) or hepatic disease (> 3 X elevations
in AST and ALT).
- Ophthalmologic conditions associated with a neo-vascular response.
- Alcohol or drug abuse, or any other disease process that, in the opinion of the PI,
will interfere with the ability of the patient to participate in the study.
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