Granulocyte-Macrophage Stimulating Factor in the Treatment of Peripheral Arterial Disease

Summary

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.

Timeline

Start

2009-09

Primary completion

2014-03

Completion

—

Outcome

Missed primary endpoint

paper mean difference in change in PWT, 53 seconds [95% CI, -6 to 112], P = .08 PMID 24247554 ↗

paper Therapy with GM-CSF 3 times a week did not improve treadmill walking performance at the 3-month follow-up. PMID 24247554 ↗

Publications

• Poole J, Mavromatis K, Binongo JN, Khan A, Li Q, Khayata M, Rocco E, Topel M, Zhang X, Brown C, Corriere MA, Murrow J, Sher S, Clement S, Ashraf K, Rashed A, Kabbany T, Neuman R, Morris A, Ali A, Hayek S, Oshinski J, Yoon YS, Waller EK, Quyyumi AA. Effect of progenitor cell mobilization with granulocyte-macrophage colony-stimulating factor in patients with peripheral artery disease: a randomized clinical trial. JAMA. 2013 Dec 25;310(24):2631-9. doi: 10.1001/jama.2013.282540.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	sargramostim	Protein / enzyme biologic	500 ug	Subcutaneous

Indications