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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

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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: 03 Sep 2026

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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

  • 27 Aug 2026 According to a Mesoblast media release, the company received a Biologics License Application (BLA) filing number from FDA and requested a modular review of its BLA for rexlemestrocel-L in prevention of life-threatening gastrointestinal bleeding due to right ventricular dysfunction in end-stage heart failure patients with a left ventricular assist device (LVAD). The request for modular review will be discussed with the Agency next quarter.
  • 23 Mar 2026 Actual primary completion date changed from 29 May 2020 to 30 Jan 2020.
  • 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.

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