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Mesoblast Stem Cell Therapy for Patients With Single Ventricle and Borderline Left Ventricle

Trial Profile

Mesoblast Stem Cell Therapy for Patients With Single Ventricle and Borderline Left Ventricle

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 20 Feb 2024

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At a glance

  • Drugs Rexlemestrocel-L (Primary)
  • Indications Hypoplastic left heart syndrome
  • Focus Adverse reactions
  • Most Recent Events

    • 14 Feb 2024 According to Mesoblast media release, the company plan to meet with FDA to discuss the pathway for approval in often-fatal congenital heart condition.
    • 14 Feb 2024 According to Mesoblast media release, the United States Food and Drug Administration (FDA) Granted Mesoblast an Orphan-Drug Designation for Revascor,following submission of results from this randomized controlled trial in children with hypoplastic left heart syndrome (HLHS).
    • 18 Jan 2024 According to Mesoblast media release, the United States Food and Drug Administration (FDA) has granted Revascor (rexlemestrocel-L) a Rare Pediatric Disease (RPD) Designation following submission of results from this study.
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