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
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
- 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.