Peripheral Arterial Disease Clinical Trial
Official title:
PROgenitor Cell Release Plus Exercise to Improve functionaL Performance in PAD: The PROPEL Study
The PROPEL study will test the hypothesis that GM-CSF combined with supervised treadmill exercise will significantly improve functional performance in patients with PAD more than GM-CSF alone or supervised treadmill exercise alone. In addition to identifying novel therapeutic options for patients with PAD, the current proposal is expected to identify mechanisms by which functional impairment is improved in patients with PAD.
Eight million men and women in the United States have lower extremity peripheral arterial
disease (PAD). PAD is expected to be increasingly common as the population survives longer
with chronic disease. Patients with PAD have greater functional impairment and faster
functional decline compared to those without PAD. However, currently there are only two FDA
approved medications for improving functional performance in patients with PAD. Furthermore,
these FDA approved medications are only modestly beneficial for improving walking performance
in patients with PAD.
Preliminary evidence suggests that increasing circulating levels of CD34+ cells with
granulocyte macrophage colony stimulating factor (GM-CSF) or other therapies may improve
walking performance in patients with PAD. However, results of small clinical trials testing
the ability of GM-CSF to improve walking performance in patients with PAD are mixed. The
association of GM-CSF with improved walking performance in PAD is not definitively
established. Preliminary data also suggest that lower extremity ischemia, induced during
walking exercise, may increase circulating CD34+ cell levels, enhance homing of CD34+ cells
to ischemic sites, and augment the ability of GMCSF to improve walking performance in PAD.
However, it is currently unknown whether the combination of GM-CSF and supervised treadmill
exercise significantly improve functional performance more than either therapy alone.
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