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A confirmatory clinical trial using Revascor (MPC-150-IM) for reduction of gastrointestinal (GI) bleeding in end-stage heart failure patients implanted with a left ventricular assist device (LVAD)

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Trial Profile

A confirmatory clinical trial using Revascor (MPC-150-IM) for reduction of gastrointestinal (GI) bleeding in end-stage heart failure patients implanted with a left ventricular assist device (LVAD)

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 09 Jul 2025

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At a glance

  • Drugs Rexlemestrocel-L (Primary)
  • Indications Heart failure
  • Focus Registrational; Therapeutic Use
  • Sponsors Mesoblast

Most Recent Events

  • 01 Jul 2025 According to Mesoblast media release, the company announced alignment with US FDA on items required for filing a Biologics License Application (BLA) regarding chemistry, manufacturing & controls (CMC), potency assays for commercial product release, and proposed design and primary endpoint for the confirmatory trial post-approval. The company intends to file for accelerated approval by the end of the year.
  • 02 Apr 2025 According to Mesoblast media release, 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 in the treatment of patients with ischemic chronic heart failure with reduced ejection fraction (HFrEF) and inflammation. The company proposed design and primary endpoint for the confirmatory trial in the meeting.
  • 02 Apr 2025 According to Mesoblast media release, company announced that, in a Type A meeting last year, FDA guided that a single confirmatory trial in class II/III patients with ischemic HFrEF and inflammation will need to be completed after any accelerated approval is obtained.

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