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: 01 Mar 2024
Price :
$35
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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
- 28 Feb 2024 According to Mesoblast media release, company met with FDA this quarter to address potential pathways to approval for REVASCOR under Regenerative Medicine Advanced Therapies (RMAT) designation. The discussion covered both Class II/III HFrEF ischemic patients with inflammation from the Phase 3 DREAM-HF 565 patient study and Class IV ischemic LVAD patients with inflammation from the 159 patient LVAD study.Minutes of the meeting are expected from FDA next month.
- 07 Mar 2023 Primary endpoint (Time to non-fatal recurrent decompensated heart failure (HF) events in the presence of terminal HF-related major adverse cardiac events (HF-MACE)) has not been met, as per results published in the Journal of the American College of Cardiology.
- 07 Mar 2023 Results assessing the efficacy and safety of mesenchymal precursor cells in patients with high-risk heart failure with reduced ejection fraction, published in the Journal of the American College of Cardiology.