A Prospective Study of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Stromal Cells, for the Treatment of Pediatric Patients Who Have Failed to Respond to Steroid Treatment for Acute GVHD

Trial Profile

A Prospective Study of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Stromal Cells, for the Treatment of Pediatric Patients Who Have Failed to Respond to Steroid Treatment for Acute GVHD

Recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Aug 2017

At a glance

  • Drugs Remestemcel-L (Primary)
  • Indications Graft-versus-host disease
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Mesoblast
  • Most Recent Events

    • 01 Aug 2017 Planned End Date changed from 1 Sep 2017 to 1 Mar 2018.
    • 01 Aug 2017 Planned primary completion date changed from 1 Jun 2017 to 1 Dec 2017.
    • 27 Feb 2017 According to a Mesoblast media release, positive data from this trial would be sufficient for filing for accelerated approval of MSC-100-IV in the United States, as per guidance received from the FDA.
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