CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 159 enrolled
Drug / intervention
Granulocyte-Macrophage Stimulating Factor (GM-CSF) +1 moredrug
Likely dose
Granulocyte-Macrophage Stimulating Factor (GM-CSF) 500 microgramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01041417
NCT01041417Phase 2Completed

Granulocyte-Macrophage Stimulating Factor (GM-CSF) and Mobilization of Progenitor Cells in Peripheral Arterial Disease: A Phase II Randomized Study

Emory University·interventional·Posted Dec 31, 2009·Updated Dec 23, 2014

In Brief

A Phase 2 clinical trial evaluating Granulocyte-Macrophage Stimulating Factor (GM-CSF) and Placebo for Peripheral Arterial Disease. Completed, enrolled 159 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 31, 2009
Enrollment StartSep 1, 2009
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 16.5 years ago

Interventions

Granulocyte-Macrophage Stimulating Factor (GM-CSF)drug

500 micrograms of GM-CSF

Placebodrug

Saline injection