# Granulocyte-Macrophage Colony Stimulated Factor (GM-CSF) in Peripheral Arterial Disease

> **NIH NIH R33** · EMORY UNIVERSITY · 2021 · $740,646

## Abstract

Peripheral arterial disease (PAD) afflicts approximately 15% of the U.S. population over 55 years of age. After
an initial asymptomatic period, patients with PAD typically develop intermittent claudication, which may
eventually progress to critical limb ischemia and unrelenting pain, ulceration and amputation. Although
exercise, smoking cessation, anti-platelet therapy, cilostazol, statins and revascularization can mitigate
symptoms, almost a third of the patients with PAD continue to suffer from intermittent claudication that
profoundly impairs their quality of life. Stem cell and progenitor cell (PC) therapy that promotes
neoangiogenesis and revascularization is an emerging treatment modality in PAD. Granulocyte -macrophage
colony stimulating factor (GM-CSF) stimulates mobilization of hematopoietic and other PCs from the bone
marrow. We have demonstrated in a Phase I dose-escalation trial and in a Phase IIA trial in patients with PAD
and claudication that GM-CSF mobilizes PCs into the circulation, is safe and results in improvement in
claudication.
We now propose to investigate the effects of mobilization of bone marrow PCs with two successive
administrations of subcutaneous GM-CSF at 3 month intervals in patients with atherosclerotic PAD and walking
impairment. Our hypothesis is that GM-CSF will improve walking distance and quality of life in patients with PAD
and walking impairment. We will measure improvement in the 6-minute walk test and in walking distance on the
treadmill and after two administrations of GM-CSF, three months apart compared to placebo. As secondary
outcomes, we will also investigate whether there is further improvement with two compared to single
administration of GM-CSF, and whether there is concomitant improvement in quality of life parameters and anklebrachial
index.

## Key facts

- **NIH application ID:** 10250085
- **Project number:** 5R33HL138657-05
- **Recipient organization:** EMORY UNIVERSITY
- **Principal Investigator:** ARSHED A QUYYUMI
- **Activity code:** R33 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $740,646
- **Award type:** 5
- **Project period:** 2017-08-15 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10250085

## Citation

> US National Institutes of Health, RePORTER application 10250085, Granulocyte-Macrophage Colony Stimulated Factor (GM-CSF) in Peripheral Arterial Disease (5R33HL138657-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10250085. Licensed CC0.

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