Actively Recruiting
Granulocyte-Macrophage Stimulating Factor (GM-CSF) in Peripheral Arterial Disease
Led by Emory University · Updated on 2024-11-27
176
Participants Needed
1
Research Sites
414 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Peripheral artery disease (PAD) is a disease in which plaque builds up in the arteries that carry blood to the head, organs, and limbs. PAD usually occurs in the arteries in the legs, but can affect any arteries. Over time, plaque can harden and narrow the arteries which limits the flow of oxygen-rich blood to organs and other parts of the body. Blocked blood flow to the arteries can cause pain and numbness. The pain is usually worse with exercise and gets better with rest. PAD can raise the risk of getting an infection which could lead to tissue death and amputation. This study is investigating whether granulocyte-macrophage colony stimulating factor (GM-CSF) improves symptoms and blood flow in people with PAD. GM-CSF is a drug that is used to stimulate the bone marrow to release stem cells. Participants in the study will be randomly selected to receive GM-CSF or a placebo. After a four-week screening phase, participants will receive injections of GM-CSF or a placebo three times a week for three-weeks. Three months later, participants will again receive injections of GM-CSF or placebo three times a week for three-weeks. At six months, the study team will follow up to see if the group that received GM-CSF had more improvement than the group that received placebo.
CONDITIONS
Official Title
Granulocyte-Macrophage Stimulating Factor (GM-CSF) in Peripheral Arterial Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants must be post-menopausal, surgically sterile, or use birth control with a negative pregnancy test within 3 days before study drug and not be breastfeeding
- Documented symptomatic peripheral artery disease
- Stable history of intermittent claudication or walking impairment for at least 2 months with no change in symptoms
- On statin therapy for at least 3 months prior to enrollment unless intolerant
- Peak walking time between 1 and 12 minutes on standardized treadmill test
- Ankle-brachial index less than 0.90 in symptomatic limb or toe-brachial index less than 0.70 if arteries are non-compressible
- On stable medical therapy for atherosclerosis for at least 2 months
- Able to give informed consent
- Diabetics must have had dilated eye exam excluding proliferative retinopathy within past 12 months
You will not qualify if you...
- Active or recent infections treated with antibiotics
- Active cancer treated within 6 months prior to randomization
- Change in statin or cilostazol therapy within 3 months prior to randomization
- Critical limb ischemia with rest pain, ulcers, or gangrene
- Lower extremity vascular surgery, angioplasty, or lumbar sympathectomy within past 3 months
- Planned participation in a structured exercise program during the study
- Prior myeloid malignancy
- Recent unstable angina, heart attack, stroke, or revascularization within 3 months
- Severe heart failure or heart muscle disease
- Exercise limitations due to conditions other than intermittent claudication
- Amputation below or above the knee or wheelchair confinement
- Use of walking aid other than a cane
- Walking impairment from causes other than PAD (e.g., Parkinson's disease)
- Uncontrolled diabetes with HbA1c over 10.0
- Chronic kidney disease with creatinine over 2.5 mg/dl or liver disease with enzymes over 3 times normal
- White blood cell count below 3,000
- Hemoglobin less than 10 g/dL
- Blood pressure above 180 systolic or 100 diastolic
- Taking immunosuppressant drugs
- Eye conditions related to new blood vessel growth
- Alcohol or drug abuse or other diseases interfering with participation
- Inability to attend study visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
K
Kiran Ejaz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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