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Expanded Access of Prochymal (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) Infusion for the Treatment of Pediatric Patients Who Have Failed to Respond to Steroid Treatment for Acute GVHD

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Trial Profile

Expanded Access of Prochymal (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) Infusion for the Treatment of Pediatric Patients Who Have Failed to Respond to Steroid Treatment for Acute GVHD

Status: Completed
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 07 Jun 2024

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At a glance

  • Drugs Remestemcel-L (Primary)
  • Indications Graft-versus-host disease
  • Focus Expanded access; Registrational; Therapeutic Use
  • Sponsors Mesoblast

    • Most Recent Events

    • 30 Apr 2024 According to a Mesoblast media release, Mesoblast intends to file the resubmission this quarter, potentially resulting in an approval for Ryoncil (remestemcel-L) in the second half of CY2024.
    • 02 Oct 2022 According to a Mesoblast media release, the company has submitted to the U.S. Food and Drug Administration (FDA) substantial new information on clinical and potency assay items identified in the Complete Response Letter (CRL) received from FDA.
    • 30 Aug 2022 According to a Mesoblast media release,BLA resubmission to FDA expected by the end of Q3 CY2022.

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