Mesenchymal Stem Cell Administration in Patients with Chronic Obstructive Pulmonary Disease: State of the Science

Table 6

Ongoing clinical trial of plerixafor mobilization of stem cells for COPD therapy.

Registry code	NCT01916577
Country	USA
Start year (follow-up)	August 2013 (1 year)
Status	Recruiting
Patient ()	COPD, cystic fibrosis, pulmonary fibrosis; age 18–70 years; awaiting lung transplant ()
Design	Randomized, open-label, Phase I safety study
Treatment	Autologous CD117+ progenitor cell mobilization; one dose of 240 μg/kg by IV infusion
Study arms & procedures	(1) Treatment (): COPD (), cystic fibrosis (), pulmonary fibrosis (); (2) Control (); Blood flow cytometric analysis of CD117+ peripheral blood cells will be collected just before the dose of plerixafor (time zero), and at 8 hours posttreatment
Primary outcomes	Efficacy: change from baseline in peripheral blood CD117+ cells per ml at 8 hours posttreatment
Secondary outcomes	Safety: number of plerixafor-related AEs/SAEs and number of patients with plerixafor-related AEs/SAEs at 30 minutes, 1 week, and 1 year posttreatment

COPD, chronic obstructive pulmonary disease; IV, intravenous; AE, adverse event; SAE, severe adverse event.