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

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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: 06 Dec 2024

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At a glance

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

Most Recent Events

  • 04 Dec 2024 According to Mesoblast media release, the company announced the United States Food and Drug Administration (FDA) has granted its second generation allogeneic, STRO3-immunoselected, and industrially manufactured stromal cell therapy Revascor (rexlemestrocel-L) Regenerative Medicine Advanced Therapy (RMAT) designation based on results from this trial and Under the RMAT designation company also plans to meet with FDA to discuss a potential approval pathway in this indication.
  • 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).

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