Authors
Anurag Mehta, Kreton Mavromatis, Yi-An Ko, Steven C Rogers, Devinder S Dhindsa, Cydney Goodwin, Risha Patel, Mohammad A Martini, Mahadev Prasad, Ali Mokhtari, Iraj G Hesaroieh, Stephen C Frohwein, Michael H Kutner, Arash Harzand, Bryan J Wells, Yazan Duwayri, Olamide Alabi, Ravi R Rajani, Luke P Brewster, Edmund K Waller, Arshed A Quyyumi
Publication date
2020/4/1
Journal
Contemporary clinical trials
Volume
91
Pages
105975
Publisher
Elsevier
Description
Background
Lower extremity peripheral arterial disease (PAD) is a public health problem and many patients with PAD experience claudication despite adequate medical and/or surgical management. Mobilization of endogenous progenitor cells using Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) is a novel therapeutic option that has shown promising results in experimental models and phase I/IIA clinical trials. The GPAD-3 trial will study the effect of two successive administrations of GM-CSF at 3-month interval for improving claudication among patients with lower extremity PAD.
Methods
We plan to recruit 176 patients in this ongoing randomized, double-blind, placebo-controlled Phase IIB trial. After screening for inclusion and exclusion criteria, eligible subjects undergo a 4-week screening phase where they perform subcutaneous placebo injections thrice weekly and walk at least three times a day …
Total citations
20222
Scholar articles
A Mehta, K Mavromatis, YA Ko, SC Rogers… - Contemporary clinical trials, 2020