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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) Dream HF-1

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) Dream HF-1

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Apr 2025

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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

  • 02 Apr 2025 According to a Mesoblast media release, the company provided an update on its plans to meet with the United States Food and Drug Administration (FDA) to discuss the accelerated approval pathway for Revascor(rexlemestrocel-L) in the treatment of patients with ischemic chronic heart failure with reduced ejection fraction (HFrEF) and inflammation.
  • 02 Dec 2024 According to Mesoblast media release, data from the study were presented in the European Journal of Heart Failure (EJHF).
  • 02 Dec 2024 Results presented in the Mesoblast Media Release.

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