Racial Differences in the Effect of Progenitor Cell Mobilization with Granulocyte-Macrophage Colony-Stimulating Factor in Peripheral Artery Disease Open Access

Kurra, Nithin Chand (Spring 2020)

Permanent URL: https://etd.library.emory.edu/concern/etds/sf268631b?locale=en


Background: Peripheral Arterial Disease (PAD) is a progressive atherosclerotic disease of the peripheral arteries. The effect of GM-CSF on improving the walking capacity in patients with lower limb PAD is unclear based on current studies. Racial differences in the severity of lower extremity arterial atherosclerosis, degree of functional impairment, and complications secondary to PAD are well established, but racial differences in the effect of GM-CSF in patients with PAD is unclear.

Methods: One hundred and fifty-nine participants with PAD were enrolled at medical centers affiliated with Emory University in Atlanta, Georgia, in a double-blinded, placebo-controlled phase IIA trial. Participants were randomized into two treatment groups (1:1): GM-CSF and placebo. Participants would either receive 500/day subcutaneous injections of GM-CSF (Leukine), three times a week for 4 weeks, or placebo. All participants were encouraged to walk at least 20mins/ day for 3 days/week. Peak walking time was recorded, and blood was collected to measure hemopoietic progenitor cell subpopulations. Differences in the impact of GM-CSF on peaking walking time between races were computed.

Results: Of the 159 participants, 79 (50.3%) were Black, and 78 (49.7%) were White with a mean age of 66 years and 62 years, respectively. Age, gender distribution, and total WBCs were significantly different between both the groups at baseline. Among Black participants, GM-CSF improved the peak walking time by +99.55 seconds (95% CI: +14.36, +184.73; p-value: 0.02) at 12 weeks, and +46.41 seconds (95% CI: -36.1, +128.93; p-value:0.27) at 24 weeks, compared to placebo. Among White participants, GM-CSF improved the peak walking time by +3.3 seconds (95% CI: -82.63, +89.23; p-value: 0.94) at 12 weeks, and +26.96 seconds (95% CI: -57.15, +111.07; p-value:0.53) at 24 weeks, compared to placebo. After adjusting for age, smoking, and baseline WBC count, there was an interaction of race on the effect of GM-CSF on PWT at 12-week follow-up (P=0.03).

Conclusions: GM-CSF did not result in a change in PWT in Whites with PAD at 12 weeks, but it improved the peak walking time in Blacks with PAD. Further investigations are needed to confirm the racial differences in the effect of GM-CSF in PAD.

Table of Contents

Abstract ii

Table of Contents. v

List of Tables and Figures. vi

Abbreviations. vii

Introduction. 1

Background. 3

Methods. 5

Study Population and Data Sources: 5

Inclusion and exclusion criteria: 5

Randomization: 6

Interventions: 6

Measurements: 7

Statistical Analysis: 7

Results. 9

Baseline Characteristics: 9

Effect of GM-CSF on PWT: 10

Effect of GM-CSF on PCs: 11

Conclusions. 15

References 16

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