Dream HF (TEVA)

A Double-blind, Randomized, Sham-procedure-controlled, Parallel-group Efficacy and Safety Study of Allogeneic Mesenchymal Precursor Cells (rexlemestrocel-L) in Patients With Chronic Heart Failure Due to Left Ventricular Systolic Dysfunction of Either Ischemic or Nonischemic Etiology

Dream HF (TEVA) [NCT02032004]

Description: The primary objective of this study is to determine whether transendocardial delivery of allogeneic human bone marrow-derived MPCs (rexlemestrocel-L) is effective in the treatment of chronic heart failure due to LV systolic dysfunction.

Biological: Allogeneic Mesenchymal Precursor Cells (MPC); Other: Sham Comparator

Primary Investigator: Chung

Drug/Device Information
Evaluate the efficacy and safety of a single transendocardial delivery of 150 M human bone marrow-derived allogeneic MPCs (rexlemestrocel-L) in improving clinical outcomes in patients with chronic HF
Rexlemestrocel-L human bone marrow-derived allogeneic MPCs which are isolated from bone mononuclear cells with anti-STRO 3 antibodies and expanded ex vivo
Myocardial locations for transendocardial delivery of rexlemestrocel-L will be defined by imaging and left ventricular mapping of the myocardium using the NOGA XP cardiac navigational system
Fifteen to 20 appropriate myocardial locations will be identified
Randomized 1:1 ratio to receive either active treatment or control (ie, a scripted sham cardiac mapping and cell delivery procedure without rexlemestrocel-L)
Teva Branded Pharmaceutical Products R&D, Inc.