Double-blind, Randomized, Sham-procedure-controlled, Parallel-Group Efficacy and Safety Study of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) in Chronic Heart Failure Due to LV Systolic Dysfunction (Ischemic or Nonischemic)

Trial Profile

Double-blind, Randomized, Sham-procedure-controlled, Parallel-Group Efficacy and Safety Study of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) in Chronic Heart Failure Due to LV Systolic Dysfunction (Ischemic or Nonischemic)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 27 Feb 2017

At a glance

  • Drugs Rexlemestrocel-L (Primary)
  • Indications Chronic heart failure
  • Focus Registrational; Therapeutic Use
  • Acronyms DREAM HF-1
  • Sponsors Mesoblast; Teva Pharmaceutical Industries
  • Most Recent Events

    • 27 Feb 2017 According to a Mesoblast media release, results of this trial will be used to guide the discussions with the United States Food and Drug Administration (FDA) in line with the 21st Century Cures Act for potential accelerated approval pathways for MPC-150-IM.
    • 14 Nov 2016 According to a Mesoblast media release, based on observed HF-MACE event rates in the trial to date, the company has decided to bring forward to first quarter of 2017 a previously planned interim analysis to assess the trial's primary endpoint.
    • 14 Nov 2016 According to a Mesoblast media release, more than 300 patients have been enrolled to date. After reviewing patient data in April and October 2016, the trial's DSMB has maintained its recommendation that the study should continue as planned.
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