Granulocyte-Macrophage Stimulating Factor (GM-CSF) in Peripheral Arterial Disease
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
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.