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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

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: 16 Oct 2019

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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

    • 16 Oct 2019 According to a Mesoblast media release, the company expects to complete filing of the rolling Biologics License Application (BLA) submission to the US Food and Drug Administration (FDA) by the end of this year
    • 29 May 2019 According to a Mesoblast media release, the company intends to request a priority review once its BLA filing is completed and accepted by the FDA.
    • 29 May 2019 According to a Mesoblast media release, the company has filed the first component of a rolling submission for a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (aGVHD).The FDA has agreed to a rolling review of the BLA which enables individual components to be submitted and reviewed on an ongoing basis rather than waiting for all sections to be completed.
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