5308W-12 A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evalua

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy, Safety, And Tolerability Of Transendocardial Injection Of Ixmyelocel-T In Subjects With Heart Failure Due To Ischemic Dilated Cardiomyopathy.

Type of Study
Heart & Vascular - Structural Heart Trials
Short Description
The main purpose of this research study is to determine the efficacy and safety of ixmyelocel-T (cells from your bone marrow) compared to placebo (an inactive solution) when given to subjects with ischemic dilated cardiomyopathy (IDCM-a condition where the heart muscle is weakened and does not pump blood properly) who have no reasonable options for surgery or other medical procedures to fix their heart. Ixmyelocel-T/placebo will be administered through an injection catheter to your heart muscle and you will be followed to evaluate the safety and effectiveness in improving your IDCM symptoms.
 
Status
Open
Principal Investigator
Paul Huang, MD
Eligibility Notes
Males and non-pregnant, non-lactating females age 30 to 86 years of age at screening with a diagnosis of ischemic dilated cardiomyopathy and a LVEF ≤35% by echocardiogram.
 
Contact Name
Deborah Tinlin, RN and Jen Nagel
Phone
206-215-2455
Alternate Phone
206-386-6462
Email
deborah.tinlin@swedish.org
Alternate Email
jennifer.nagel@swedish.org